Rajiv Gandhi University of Health Sciences s189

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BENGALURU, KARNATAKA.

SYNOPSIS PROFORMA FOR REGISTRATION OF SUBJECT

FOR DISSERTATION

‘‘A STUDY TO EVALUATE THE EFFECTIVENESS OF

PLANNED TEACHING PROGRAMME ON KNOWLEDGE

REGARDING PREVENTION AND MANAGEMENT OF

THROMBOPHLEBILITS IN CANCER PATIENTS RECEIVING

CHEMOTHERAPY AMONG STAFF NURSES IN SELECTED

HOSPITALS AT BANGALORE’’.

Mr. VIJAYAKUMAR

1ST YEAR M.Sc. NURSING

MEDICAL SURGICAL NURSING

GOUTHAM COLLEGE OF NURSING

RAJAJINAGAR, BENGALURU-560010

1 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BENGALURU, KARNATAKA.

SYNOPSIS PROFORMA FOR REGISTRATION OF

SUBJECTS FOR DISSERTATION

1. Name of the candidate and address MR.VIJAYAKUMAR 1ST YEAR M.Sc. NURSING, GOUTHAM COLLEGE OF NURSING, BENGALURU-10

2. Name of the institution GOUTHAM COLLEGE OFNURSING RAJAJINAGAR, BENGALURU-560010

3. Course of study and subject 1ST YEAR M.Sc. NURSING MEDICAL SURGICAL NURSING

4. Date of admission to course 25-6-2012

5. Title of the topic ‘‘A STUDY TO EVALUATE THE EFFECTIVENESS OF PLANNED TEACHING PROGRAMME ON KNOWLEDGE REGARDING PREVENTION AND MANAGEMENT OF THROMBOPHLEBILITS IN CANCER PATIENTS RECEIVING CHEMOTHERAPY AMONG STAFF NURSES IN SELECTED HOSPITAL AT BANGALORE’’

NEED FOR THE STUDY:

Cancer is a major life – threatening disease. The World Health Organization

predicts that the global numbers of new cancer patients are expected to be increased

15 millions and more than 11 million will die from this disease in the year 2011.20 to

2 40% of cancer patients show emotional distress. Cancer affects people in worldwide approximately 10 million people are diagnosed with cancer and more than 6 million die of the disease every year. About 22.4 million persons were living with cancer in the year 2012 .1

In UK more than 324,500 people were diagnosis with cancer in 2010.The crude rate shows that this equates to around 521 cases for every 100,000 people. Each year more than 1.50 million people are diagnosed with cancer in the United States, each year more than half a million people die from this disease. The number of new cases ranged from 3.72 million in south eastern Asia and it was estimated account for around 9% of all deaths and 27% of cancer cases were detected in 2009.2

Cancer prevalence in India is estimated to be around 2.5 million with over 8,

00,000 new cases and 5, 50,000 deaths occurring in each year due to this disease.

Every year on 4 February with support of International union against cancer to promote ways to ease the global burden of cancer as “World Cancer Day” Preventing cancer and raising quality of life for cancer patients are recurring themes.1

Chemotherapy is the treatment of cancer with one or more cytotoxic antineoplastic drugs ("chemotherapeutic agents") as part of a standardized regimen.

Chemotherapy may be given with a curative intent or it may aim to prolong life or to palliate symptoms. Traditional chemotherapeutic agents act by killing cells that divide rapidly, one of the main properties of most cancer cells. This means that chemotherapy also harms cells that divide rapidly under normal circumstances: cells in the bone marrow, digestive tract, and hair follicles. This results in the most

3 common side-effects of chemotherapy: myelosuppression(decreased production of blood cells, hence also immunosuppression), mucositis(inflammation of the lining of the digestive tract), and alopecia (hair loss).3

Cancer Patients receiving chemotherapy require some form of vascular access as a critical component of their medical care. However, the insertion and daily use of these devices are associated with risks and complications. Complications due to intravenous administration of drugs and fluids are the direct result of trauma to the lumen of the vein i.e., Thrombophlebitis. They occur somewhat frequently but are rarely serious, despite the fact that considerable damage to the vessel wall has usually occurred before the problem is discovered.4

“ Thrombo” means “clot”, “Phlebitis” means “inflammation of a vein”

Thrombophlebitis occurs when a blood clot causes inflammation in one or more of the veins near the surface of the skin. Damage to a vein can occur as a consequence of indwelling catheters, trauma or the infection of the irritating substances. Any form of injury to a blood vessel can result in thrombophlebitis. In intravenous thrombophlebitis, the blood clot usually attaches firmly to the wall of the affected vein. The location of the clot can sometimes be seen by the unaided eye. Blood clots are hard and can usually be detected by using palpation. 5

According to WHO cancer is a second leading cause of death worldwide. In

2011, 7.2 million deaths (around 13% of all deaths) were formed. An estimated 12.7 million new cancer cases were diagnosed.10 million new cancer cases seen each year.

More than half of chemotherapy cases have more incidence of thrombophlebitis.6

4 In India the estimated number of new cancer cases per year is about 7 lakhs and over 3.5 lakhs people die of cancer each year. According to Indian Council of

Medical research, the incidence of thrombophlebitis among cancer patients is 18.3%.

Thrombophlebitis is a common complication associated with chemotheraptic patients, affecting between 27% and 70% of all clients receiving intravenous therapy.7

In the year 2011, the annual hospital report of Karnataka, stated that the incidence of Thrombophlebitis was (78%) in ICU as compared to (30%) in general wards. The study highlighted the cause as lack of physicians, nurses and poor standard of care provided by health care personnel.8

An Indian Council of Medical Research (ICMR) shows that Bangalore has

113 male and 139 female cancer patients per 100,000 populations. Among these 1/3rd patients shows the symptoms of thrombophlebitis receiving chemotherapy.9

The use of intravenous device has long been established as a life saving and important part of total patient management. However, such devices are not without risks and their use is frequently complicated by local or systemic infections and complications. Thus it is implicated that the staffs who are involved in the management of intravenous devices are to base their practice on what is evidence- based and initiate interventions which have been found to be effective in reducing the risks of thrombophlebitis and other hospital-acquired infections.10

A study was carried out on staff nurses regarding the clinical importance, diagnosis, incidence, and pathogenesis of peripheral vein infusion Thrombophlebitis

5 among cancer patients, including catheter-related and patient-related risk factors. The study reviewed the evidence linking thrombosis, particularly prothrombotic states such as the inherited thrombophilic disorders, with peripheral vein infusion

Thrombophlebitis. Peripheral vein infusion Thrombophlebitis occurs in 25% to 35% of hospitalized patients with peripheral intravenous catheters and has both patient- related implications (e.g., sepsis) and economic consequences (e.g., extra nursing time). Although duration of catheterization, catheter-related infection, and catheter material are important risk factors for peripheral vein infusion Thrombophlebitis, patient-related risk factors are not well elucidated.11

A hospital staff nurse probably spends up to two-thirds of their shift on IV- related responsibilities like venipunctures or inserting cannulas, hanging fluids, calculating and administering IV medications, assessing IV sites and removing IV lines. The frequent use of intravenous catheters carries with it, many potential risks, both mechanical and infections. Not all intravenous complications can be avoided but assessment skills, recognizing their key signs and symptoms, ability to identify problems can minimize risks for patients and will help avoid life-threatening situations.12

A study was conducted on nurse’s knowledge regarding in IV therapy. The

Studies revealed that IV education for nurses in practice helped reduce complication rates. Dated research also indicated that nursing programs were reluctant to provide

IV instruction that included advanced skills, such as catheter insertions. A survey was distributed at the completion of an ADN program to evaluate perceived knowledge and comfort related to IV therapy, as well as information about IV education

6 throughout the program. Results: nurses who participated in the workshop perceived having a higher level of comfort and knowledge of several IV content areas than those who participated in the course or had no elective IV education. Conversely, participants in the workshop and course felt more comfortable with central line dressing changes and IV insertions than students who did not take either IV educational offering. The study Concluded that IV education appeared to provide adequate knowledge and comfort with IV therapy. However, optional IV education benefited students who wanted more in depth IV knowledge and skills.13

The prevention of Thrombophlebitis is very much important in hospital set up.

The nurses have more responsibility to prevent the occurrence and complication related to Thrombophlebitis. Special attention should be carried out for this purpose.

An important goal of this study is to provide planned teaching programme on knowledge regarding prevention and management of thrombophlebilits in cancer patients receiving chemotherapy. The intent is to improve the knowledge of staff nurses and implementation of that knowledge to prevention and manage the thrombophlebilits in cancer patients receiving chemotherapy.

6.2 REVIEW OF LITERATURE:

Review of literature refers to activities involved in identifying and researching for information on a topic and developing an understanding of the state of knowledge on that topic.

Review of literature is categorized under the following headings:

7 6.2.1: Studies related to thrombophlebitis among cancer patients.

6.2.2: Studies related to knowledge of staff nurses regarding management of

thrombophlebitis among cancer patients.

6.2.3: Studies related to effectiveness of structured teaching programme.

6.2. 1: Studies related to thrombophlebitis among cancer patients.

A Study was conducted on Cancer patients receiving chemotherapy are at increased risk of thrombosis. The aim of the study was to evaluate the thromboembolic risk and the benefit of thromboprophylaxis according to type of chemotherapy. The Cancer outpatients were randomly assigned to receive subcutaneous injections of nadroparin or placebo. The incidence of symptomatic TEs was assessed according to the type of chemotherapy. Results were reported as risk ratios with associated 95% CI and two-tailed probability values. The results shows that 769 and 381 patients have been evaluated in the nadroparin and placebo group, respectively. In the absence of thromboprophylaxis, the highest rate of TEs was found in patients receiving gemcitabine- (8.1%) or cisplatin-based chemotherapy (7.0%).

The combination of gemcitabine and cisplatin or carboplatin increased the risk to

10.2%. Thromboprophylaxis reduced TE risk by 68% in patients receiving gemcitabine; with a further decrease to 78% in those receiving a combination of gemcitabine and platinum. The study Concluded that patients undergoing chemotherapy including gemcitabine, platinum analogues or their combination are at higher risk of TEs. The results also suggest that outpatients receiving chemotherapy regimens including these agents might achieve an increased benefit from thromboprophylaxis with nadroparin.14

8 A study was conducted on the efficacy and safety of very-low-dose warfarin was assessed in a small population of women receiving chemotherapy for metastatic breast cancer.21 Patients received either warfarin (1 mg/d for 6 weeks, followed by adjustment to maintain an INR of 1.3 to 1.9) or placebo until 1 week after the end of chemotherapy. A total of 7 patients in the placebo group (4.4%) had thromboembolic events, compared with only 1 event in the warfarin-treated group, corresponding to a relative risk reduction of 85% associated with the use of warfarin. Bleeding events were observed in 5.3% of warfarin patients compared with 3.1% of placebo patients.15

A study was conducted to assess the incidence and factors associated with the following outcome endpoints: severe sepsis or septic shock at presentation, cancellation of antineoplastic chemotherapy, and mortality at week 12. A prospective single-center observational study including all adult patients with solid cancer who experienced a TIVAP-related infection. Patients were prospectively followed for 12 weeks. Among 1728 patients receiving antineoplastic chemotherapy during the inclusion time, 72 had an episode of TIVAP-related infection (4.2%) and were included in the study (median age, 60 yr; range, 28-85 yr). The incidence of complications was 18% for severe sepsis or septic shock (13/72 patients), 30% for definitive cancellation of antineoplastic chemotherapy (14/46 patients who still had active treatment), and 46% for death at week 12 (33/72 patients). Factors associated with severe sepsis or septic shock were an elevated C-reactive protein (CRP) level and an infection caused by Candida species; 4 of the 13 severe episodes (31%) were due to coagulase-negative staphylococci (CoNS). Factors associated with death at week 12 were a low median Karnofsky score, an elevated Charlson comorbidity index, the metastatic evolution of cancer, palliative care, and an elevated CRP level at

9 presentation. Hematogenous complications (that is, infective endocarditis, septic thrombophlebitis, septic pulmonary emboli, spondylodiscitis, septic arthritis, or organ abscesses) were found in 8 patients (11%). In conclusion, patients' overall condition and elevated CRP level were associated with an unfavorable clinical outcome after a

TIVAP-related infection. Candida species and CoNS were responsible for severe sepsis or septic shock.16

6.2.2 Studies related to knowledge of staff nurses regarding

A study was conducted on the application of evidence based nursing to explore the better nursing care of preventing chemotherapeutic phlebitis. About 30 cases of leukemia with total 120 times of chemotherapy were randomly divided into two groups.

The evidence- based support was given to the experimental group, using 2% lidocaine plus

25% magnesium sulfate for wet dressing synchronously during chemotherapy. The control group received conventional chemotherapy. Through the clinical observations of the two groups, the effect of vascular protection of the experimental group was significant; the effective rate was 93.3%. Thus the study concluded that attaching importance to the protection of vein and the use of drug wet dressing simultaneously in chemotherapy for childhood leukemia can be effective in preventing phlebitis caused by chemotherapy and ensuring the smooth completion of chemotherapy.17

A Study was planned and applied in 2 stages. Stage I was applied to determine the knowledge of nurses working in the internal medicine, surgery, obstetrics and gynaecology, paediatrics. Stage II consisted of observation of all patients who had intravenous catheters for symptoms of phlebitis for 5 days and the interventions the nurses used for the patients who had phlebitis. In stage I, questionnaires were used to determine the knowledge of the nurses; in stage II, 2 investigators observed the

10 patients. Nurses were found to have high knowledge levels, but their practices were not suitable to their knowledge levels. Of the patients who participated in the study,

67.24% showed symptoms of phlebitis. Study found that there was a significant relationship between the selection of the vein and the occurrence of phlebitis in patients who had an intravenous catheter. Study found that nurses were having less knowledge in selection of cannulation site .18

A study was conducted to examine whether specially trained nurses change their actions to decrease complications when using cannulae. The study included 36 nurses assigned to experimental and control groups. The experimental group followed an education programme explaining how to use and take care of a peripheral intravenous vein cannula. To evaluate the intervention document analysis, observations and patient interviews were performed in 99 patients with

172 peripheral intravenous cannula in situ for less than 24 hours. After the education programme, fewer complications, more carefully performed care and handling, and better documentation and information were found in the experimental group.

Nurses in the control group followed current routines, which resulted in a greater degree of complications. Education in evidence-based care and handling gives nurses the opportunity to improve their ability to use theoretical knowledge in clinical problems.19

A study was conducted to describe how nurses (n = 37) planned, took care of, and documented peripheral intravenous (vein) cannulae (PIV) and what controls their way of action. Knowledge, experience, and routine were said to govern the care and handling of peripheral intravenous cannula. The nurses' intention was that a peripheral intravenous cannula should be inserted for 1-3 days, but all of them were aware of peripheral intravenous cannula being inserted considerably longer, the

11 reasons being forgetfulness, carelessness, mistake, no one to take responsibility, routines and stress. Patients who had received drugs or solutions daily were given less information and furthermore the same peripheral intravenous cannula entry was used for drugs, solutions and blood. Only one nurse documented the insertion and the removal of a peripheral intravenous cannula. The nurses' personal comments were that the area was neglected and there were great variations in the care and handling of peripheral intravenous cannula. Their task is to systematically identify the patients' needs and risk factors, and to analyse, diagnose, plan, implement and evaluate the care given. Using a standardised guide could be a way to reduce the frequency of complications in the daily care of peripheral intravenous cannula.20

6. 2.3: Studies related to effectiveness of structured teaching programme.

A study was conducted to assess Effectiveness of massage therapy in the treatment of thrombophlebitis. The aim of the study was to evaluate the effectiveness of a massage therapy for thrombophlebitis treatment in a group, low cost, nonclinical setting. .A prospective, randomized, clinical trial was used for the study .Eighty men and women were randomly assigned to 1 of 2 groups. The intervention group consisted of a neurologist and physical therapist intake and discharge, 18 group- supervised exercise therapy sessions, 2 group stress management and relaxation therapy lectures, 1 group dietary lecture, and 2 massage therapy sessions. The control group consisted of standard care with the patient's family physician. Outcome measures included self-perceived pain intensity, frequency, and duration; functional status; quality of life; health status; depression; prescription and nonprescription medication use; and work status. Outcomes were measured at the end of the 6-week

12 intervention and at a 3-month follow-up. The study was showed that 41of 44 patients from the intervention group and all 36 patients from the control group completed the study. There were no statistically significant differences between the 2 groups before intervention. Intention to treat analysis revealed that the intervention group experienced statistically significant changes in self-perceived pain frequency (P

=.000), pain intensity (P =.001), pain duration (P =.000), functional status (P =.000), quality of life (P =.000), health status (P =.000), pain related disability (P =.000), and depression (P =.000); these differences retained their significance at the 3-month follow-up. There were no statistically significant changes in medication use or work status. The study was revealed that Positive health related outcomes in cancer patients can be obtained with a low cost, group, multidisciplinary intervention in a community based nonclinical.21

A study was conducted for nosocomial infections, to determine the interplay of factors that contribute to the risk of thrombophlebitis in peripheral non-steel, non- butterfly intravenous catheters. The study includes 3094 patients with 5161 total episodes of PICs from the day of admission until the day of discharge. The results showed that the overall rate of phlebitis was 2.3% and the rate of intravenous catheter-associated bacteremia was 0.08%. In all other circumstances, 48-72 hours was recommended.14 Reviewed 23 literature references to identify the optimal time for the routine replacement of intravenous administration sets when the infuscate or parenteral nutrition (lipid and non-lipid) solutions or infusions (excluding blood and blood products) were administered to people in hospital via central or peripheral venous catheters. The study concluded that IV administration set that does not contain

13 lipids, blood or blood products may be left in place for intervals of up to 96 hours without increasing the incidence of infection.22

6.3 STATEMENT OF THE PROBLEM

‘ ‘ A STUDY TO EVALUATE THE EFFECTIVENESS OF PLANNED

TEACHING PROGRAMME ON KNOWLEDGE REGARDING PREVENTION

AND MANAGEMENT OF THROMBOPHLEBILITS IN CANCER PATIENTS

RECEIVING CHEMOTHERAPY AMONG STAFF NURSES IN SELECTED

HOSPITALS AT BANGALORE’’.

6.4 OBJECTIVES OF THE STUDY

• To assess the pre-test knowledge regarding prevention and management of

Thrombophlebilits in cancer patients receiving chemotherapy.

• To evaluate the effectiveness of planned Teaching Programme on knowledge

regarding prevention and management of Thrombophlebilits in cancer patients

receiving chemotherapy .

• To find an association between knowledge score with their selected demographic

variables.

6.5 OPERATIONAL DEFINITIONS

1. Effectiveness:

Determine the extent to which the planned teaching programme on prevention and management of Thrombophlebilits in cancer patients receiving chemotherapy has

14 achieved desired effect in terms of gain in knowledge measured by knowledge questionnaires.

2. Planned teaching programme:

Systematically organized teaching programme designed to provide information about prevention and management of Thrombophlebilits in cancer patients receiving chemotherapy for staff nurses by using various AV aids for the duration of 1 hour.

3. Knowledge:

Correct responses to structured knowledge questionnaires about prevention and management of Thrombophlebilits in cancer patients receiving chemotherapy.

4. Prevention:

Curtailing or limiting the occurrence of thrombophlebitis among cancer patients receiving chemotherapy.

5. Management:

Refers to an action taken to combating of Thrombophelibitis in cancer patients receiving chemotherapy among staff nurses.

6. Thrombophlebitis:

The injury of the blood vessels due to the continuous exposure and irritation of the veins to intravenous fluids and medications.

15 7. Cancer patients:

The patients who diagnosed to be a cancer and receiving chemotherapy treatment.

8.Chemotherapy:

Refers to the treatment of the disease especially cancer by using chemical agents or drugs that are selectively toxic to the causative agent of the disease.

9. Staff Nurses:

Staff nurses who has qualified BSc(N) ,GNM or PC BSc (N) registered nurses working in selected oncology hospital at Bangalore.

6.6. ASSUMPTIONS:

 Cancer patients receiving chemotherapy treatment are more prone to get

Thrombophlebitis

 Staff nurses may have basic knowledge regarding prevention and management

of Thrombophlebilits in cancer patients receiving chemotherapy

 Planned teaching programme may enhance the knowledge of staff nurses

regarding prevention and management of Thrombophlebilits in cancer patients

receiving chemotherapy.

6.7. DELIMITATIONS

1. The study is delimited to staff nurses of both genders.

2. The study is delimited to assessment of knowledge aspect only.

16 6.8. HYPOTHESES

1. H1- there will be a significant difference between the mean pretest and post

test knowledge score of staff nurses after administering structured teaching

programme.

2. H2- There will be a significant association between the knowledge score with

their selected demographic variables.

MATERIALS AND METHODS

7.1 Sources of Data

The data will be collected from the staff nurses in selected hospitals at Bangalore.

7.1.1 Research design

Pre experimental (one group pre test and post test) design will be used for the study.

7.1.2 Settings

The study will be undertaken in a selected oncology hospital, at Bangalore.

7.1.3 Population

Staff nurses working in selected oncology hospital, at Bangalore.

7.2. Method of data collection

7.2.1 Sampling procedure

Purposive sampling technique.

7.2.2 Sample size

17 In this study sample size will be 60 staff nurses from selected hospital bangalore.

7. 2.3. Inclusion criteria

This study includes staff nurses who are:-

1. Available at the time of study

2. Staff nurses working in selected oncology hospital, at Bangalore.

3. Able to read English.

7.2.4. Exclusion criteria

This study includes staff nurses who are:-

1. Exposed to same type of teaching programme.

2. Not willing participate.

7.2.6 VARIABLES

1. DEPENDENT VARIABLES: Structured teaching programme.

2. INDEPENDENT VARIABLES: Knowledge of staff nurses about management of

thrombophelibitis among cancer patients reciving chemotherapy

3. DEMOGRAPHIC VARIABLE : Age,sex, Educational qualifications,Religion,

type of family,etc.

7.2.5 Instrument used:

The instrument consist of

Part 1: Demographic structured questionnaire.

Part 2: Structured knowledge questionnaire

18 7.2.6 METHOD OF DATA Prior to study a formal permission will be obtained from concern authority. COLLECTION  Informed consent will be taken and the purpose of the study will be explained to the staff Nurses.  Structured demographic and structured knowledge questionnaire will be used to conduct the pretest.  STP will be given on the same day.  Post test will be conducted on 7th day by using same tool.  Duration of the propose study is 30 days. 7.2.7 METHODS OF DATA The investigator will analyze the data obtained ANALYSIS AND by using descriptive and inferential INTERPRITATION statistics.The plan of data analysis will be as follows:

1. Organize the data in Master sheet/computer.

2. Frequencies and percentage of analysis of demographic data.

3. Descriptive statistics: Frequency,percentage distribution, mean and standard deviation will be used.

4. Inferenial statistics: paired ‘T’ test will be used to determine the significance of the difference between the mean pre-test and post test knowledge score.

5. Chi-square will be used to determine the association between pre-test knowledge level and selected variable.

19 7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR

INTERVENTION TO BE CONUCTED ON PATIENTS OR OTHER HUMAN

OR ANIMALS?

Yes; the investigator needs to assess the knowledge of staff nurses prevention and management of Thrombophlebilits in cancer patients receiving chemotherapy and also to administer planned teaching programme after getting the informed consent from them.

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED ?

Yes; Administrative permission will be obtained from concerned authority.

Confidentially and anonymity of the subjects will be maintained.

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Senior Lecturer. University of the West of England, Gloucester. November, 2002.

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22.Idiopathic Superficial Thrombophlebitis and the Incidence of Cancer in Primary

Care Patients Frederiek F. van Doormaal, MD,1 Selma Atalay,1 Henk J. Brouwer,

MsC,2 Eit-Frits van der Velde, MD,2 Harry R. Büller, MD,1 and Henk C. van Weert,

9. Signature of the candidate

10. Remarks of the guide

11. Name and designation of (in block letters)

23 11.1 Guide MRS.R. MANIMALA. ASSO.PROFESSOR

DEPT. OF MEDICAL SURG NURSING

BANGALORE

11.2 Signature

11.3 Co-guide (if any)

11.4 Signature

MRS.R. MANIMALA. 11.5 Head of the department ASSO.PROFESSOR

DEPT. OF MEDICAL SURG NURSING

BANGALORE

11.6 Signature

12. 12.1 Remarks of the Chairman and Principal

12.2 Signature