Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore s12

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. Name of the candidate and JOBY M JOSEPH address I YEAR M. Sc. NURSING (in block letters) T JOHN COLLEGE OF NURSING GOTTIGERE BANGALORE-83

T JOHN COLLEGE OF NURSING 2. Name of the Institution GOTTIGERE BANGALORE-83

3. Course of Study and Subject M. Sc. NURSING MEDICAL SURGICAL NURSING

4. Date of Admission to the 15.06.2009 course

5. Title of the Topic

“ EVALUATE THE EFFECTIVENESS OF THERAPEUTIC BACK MASSAGE ON QUALITY OF SLEEP AMONG THE ELDERLY BEDRIDDEN”

6 BRIEF RESUME OF THE INTENDED WORK

. INTRODUCTION

1 Medical surgical nursing is the backbone of modern nursing and the practice foundation of virtually all health care institutions1. The geriatric health nursing one of the sub branches of medical surgical nursing which requires more attention and need for the care of old age people. The old age associated with many problems due to aging process. One of the common complaints among the elderly is sleep disturbances mainly those who are in the bed for long time and immobile.2

Sleep disturbances in the old age is insomnia, sleep apnoea, restless legs syndrome, parasomnias, and/or sleep-related eating disorders. Many medical disorders can produce insomnia including asthma, COPD, bronchitis, GERD, dementia, Parkinson’s disease, rheumatoid arthritis, fibromylagia, and hyperthyroidism. Often patients may have poor sleep habits/hygiene which leads to sleep fragmentation. Insomnia most common complaint in sleep disturbances.

The decreased or lack of sleep is known as insomnia.2

Compared to people with normal sleep, patients with insomnia are more likely to experience anxiety and depression and suffer other serious consequences, such as work- and driving-related accidents and an overall increase in mortality rate.3

Acute insomnia is transient short term or adjustment insomnia. The duration of acute insomnia is one night to a few weeks and may be related to environmental or occupational stress or illness. The acute insomnia typically resolves with adaptation or removal of the stressor. Acute insomnia can lead to chronic insomnia if left untreated.

Chronic insomnia is generally defined as difficulty initiating or maintaining nocturnal sleep or difficulty achieving restorative sleep for longer

2 than one month, associated with significant distress and without obvious relationship with other disorders or substance abuse.4

Chronic insomnia can either be primary or co-morbid and waxes and wanes over time. Primary insomnia is the term applied when no co-existing disorder can be identified In addition, primary insomnia often results in other health-related sequelae and patients may present to their primary care physician with major complaints other than insomnia, such as daytime sleepiness, fatigue, mood changes or other symptoms which have a negative impact on daytime functioning. The primary insomnia common among old age people5

Co-morbid insomnia may be obscured by an underlying condition, such as chronic pain, sleep disorders, medications, substance abuse, or a host of other medical and psychiatric conditions 6

Consequently, a diagnosis of insomnia may not be obvious and the

National Centre on Sleep Disorders Research at the National Institutes of Health recently recommended that secondary insomnia be termed ‘co-morbid insomnia’ rather than a symptom of other disorders, emphasizing that large numbers of individuals with chronic illness suffer from fragmented sleep .6

The management of insomnia included the pharmacological and non pharmacological management of insomnia. One of the non pharmacological management of insomnia is therapeutic back massage. Massage therapy means therapists can massage the back by press, rub, and otherwise manipulate the muscles and other soft tissues of the body. They most often use their hands and fingers. Therapeutic back massage induce circulation, relieves pain ,produce relaxation, sense of well being ,maintain hygiene and promote sleep.7

6..1 NEED FOR THE STUDY

3 In the year 2002, all over the world 605 million old person and 400 million living in the low income countries. By 2025, the numbers of elderly expected are 1.2 billion world wide and 840 million in the low income countries.

In 2001 the elderly (people above the age of 60 years) comprise 7.5 percent of total Indian population, and making health care available and accessible to them is one of the health priorities of the country.8

India now has the second largest aged population in the world. The small- family norm means that fewer working, younger individuals are called upon to care for an increasing number of economically unproductive, elderly persons.7

According to the findings of the 60th NSSO Round, the proportion of aged persons who cannot move and are confined to their bed or home ranges from 77 per 1000 in urban areas to 84 per 1000 in rural areas Morbidity9

The epidemiological data on health problems in elderly reported that in

2007 as follows: Poor Vision (45.4%), Hypertension ( 38.2%), Arthritis ( 36.1%),

Bowel complaints ( 31.6%), Depression ( 23.6%), Difficulty in Hearing ( 20.5%),

Weight Loss (19.6%), Anaemia (16.8%), Urinary complaints (13.4%), Diabetes

(13.3%), Fall ( 8.7%), IHD ( 7.7%), Asthma ( 6.6%), COPD ( 4.8%), and

Tuberculosis (3.1%) were the common health problems highlighted by the study.

These all health problems mostly causes sleep disturbances especially bedridden due to any significant problems create sleep disturbances.8

A study was conducted in a skilled-care geriatric hospital regarding sleep disturbances and mortality risk among 272 patients who were aged, in the presence or absence of sleep disturbances were examined by hourly observations of patients over 2 weeks at baseline, and they were prospectively followed up for

2 years to assess mortality. Results show that mortality after 2 years was

4 significantly higher in the night time insomnia, daytime sleepiness, and sleep- onset delay groups. Further, adjusted for age, gender and activities of daily living status, the presence of night time insomnia and sleep-onset delay remained associated with a higher risk of mortality. The study concluded that sleep disturbance may be one of the symptoms indicating poor health or functional deficits, and be an independent risk factor for survival of elderly.10

A study was conducted to assess the adverse effects, sedative-hypnotic drugs (SHDs) are widely used in institutional settings serving the elderly. Using a

2 (Intervention, Control) x 3 (Baseline, Intervention, Withdrawal) mixed design with random assignment to the intervention (n = 15) or control (n = 13) group, the authors sought to determine if a non pharmacological sleep intervention (massage at bedtime) could reduce "as-needed" SHD (PRN-SHD) usage. Each phase of this pilot lasted 7 days and PRN-SHD usage was monitored via chart review. Results, indicating a 13% greater reduction in requests for PRN-SHD for the intervention group when it received massage, approached statistical significance for the quadratic planned comparisons (p = .17) despite limited power (.28) for the observed effect size of .07. While preliminary, results suggest that massage at bedtime may reduce PRN-SHD usage with older adults. Randomized controlled studies with larger samples are needed.11

The number of elderly in the population will be more than double in the next 40 year12. Lindeman(1975) developed an initial list of research priorities for clinical practice that included nursing interventions focused on care of the elderly ,pain management and patient education.13

From the above review and researcher own observation in professionally

5 found that the therapeutic back massage is very effective in promoting the sleep.

Very few studies supporting the therapeutic back massage. The investigator plan to conduct the study to evaluate the effectiveness of therapeutic back massage on quality of sleep among elderly bedridden. 6.2 REVIEW OF LITERATURE

The review of literature discussed under following headings

Studies related to the quality of sleep

A study was conducted on 24 healthy subjects, who wore an actigraph for seven nights while adhering to a regular sleep-wake schedule followed by a 90-minute, polysomnographically-recorded nap. The influence of two-night and seven-night averages of total sleep time immediately prior to the nap on nap architecture was examined. According to the results, less prior nightly total sleep time increased the percentage of REM sleep during the nap. Average total sleep time did not affect any other architecture variable of the nap. Bed and wake time appear to influence REM sleep percentage only in the short-term. “The findings of our study indicate that minute differences in 'normal' sleep duration influence the percentage of REM sleep obtained in a subsequent afternoon nap," said Kanady. "Specifically, 10 minutes less sleep per night led to a 1.3 percent increase in nap REM percentage. These results may have important implications for studies examining sleep-dependent memory consolidation, particularly.14

Studies related to the sleep disturbances in elderly

A study was conducted about the Treatment of elderly primary insomnia

Participants were 149 elderly patients with DSM-IV primary insomnia including evidence of daytime sleepiness (53 males, 96 females; mean age 71.3yrs, range

65-86yrs). A randomized, multi centre, double-blind, placebo-controlled, parallel-

6 group design was used to assess the hypnotic efficacy of EVT 201 1.5 and 2.5mg during seven consecutive nights. Results shows that the compared to placebo,

EVT 201 1.5 and 2.5mg increased TST (30.9, 56.4min, respectively; p=0.0001, p<0.0001); reduced wake after sleep onset (WASO; -15.2, -36.1min, respectively; p=0.014, p<0.0001); reduced latency to persistent sleep (LPS; -15.9, -19.9min, respectively; p=0.009, p=0.001). The 2.5mg dose also reduced WASO in hours 5-

8 (-16.3min, p=0.001). The study concluded that EVT 201 improved PSG measures of sleep onset and sleeps maintenance and significantly reduced daytime physiological sleep tendency. These findings suggest that treatment of primary insomnia in older patients has the potential to improve daytime sleepiness as well as sleep.15

A study was conducted on evaluate the efficacy and tolerability of

Gaboxadol in the treatment of adult and elderly patients with primary insomnia.

Randomized, double-blind, placebo-controlled, multi centre, 30-night, polysomnography studies in sleep laboratory. Among primary insomnia, 18-64 y

(adult study), or > or =65 y (elderly study) patients Primary endpoints were wake after sleep onset (WASO) and latency to persistent sleep (LPS). Slow wave sleep

(SWS) was a secondary endpoint. Analyses were based on the change from baseline for the average of nights 1/2, and nights 29/30, and compared Gaboxadol versus placebo. The study concluded that the maximum studied doses of

Gaboxadol (GBX15 in adult patients and GBX10 in elderly patients) were effective at enhancing objective polysomnography measures of sleep maintenance and SWS, and also some subjective sleep measures, over 30 nights but had little or no effects on sleep onset. The clinical relevance of the enhancement of SWS by

7 Gaboxadol is unclear.16

A Cross-sectional study was conducted on the prevalence, characteristics, and risk factors of sleep and daytime sleepiness problems in this specific population among eight hundred and seventy six patients with CP treated with long-term Opioids. Results shows that Insomnia-type sleep problems and combined sleep and sleepiness problems were reported by 87 percent and 49 percent of the sample, respectively. The study concluded that sleep and daytime sleepiness problems are common among Opioid-treated primary care patients with CP and seem to be related mainly to depression and pain severity. Physicians caring for Opioid-treated patients with CP may want to assess them for sleep disorders as a part of routine CP care.17

A Randomized, double blind, controlled clinical trial was conducted to evaluate 6 months' Eszopiclone treatment upon patient-reported sleep, fatigue and sleepiness, insomnia severity, quality of life, and work limitations. 54 research sites in the U.S. among830 primary insomnia patients who reported mean nightly total sleep time (TST) < or = 6.5 hours/night and/or mean nightly sleep latency

(SL) >30 min. Intervention given as Eszopiclone 3 mg or matching placebo.

Results shows that patient-reported sleep and daytime function were improved more with Eszopiclone than with placebo at all months (P <0.001). Eszopiclone reduced Insomnia Severity Index scores to below clinically meaningful levels for

50% of patients (vs. 19% with placebo; P <0.05) at Month 6. SF-36 domains of

Physical Functioning, Vitality, and Social Functioning were improved with

Eszopiclone vs. placebo for the Month 1-6 average (P < 0.05). Similarly, improvements were observed for all domains of the Work Limitations

8 Questionnaire with Eszopiclone vs. placebo for the Month 1-6 average (P

<0.05The study concluded that this is the first placebo-controlled investigation to demonstrate that long-term nightly pharmacologic treatment of primary insomnia with any hypnotic enhanced quality of life, reduced work limitations, and reduced global insomnia severity, in addition to improving patient-reported sleep variables.18

Studies related to therapeutic back massage and quality of sleep among elderly

A study was conducted on examining the effects of massage therapy for senior citizens and they found that at least 50 percent of the elderly who were tested showed a reduction in their rates of breathing, an increase in their range of motion, an improvement of their postures, development of more body awareness, their skin took on healthier colors and their muscle tones and promotion of sleep were enhanced. The same study also showed that 100 percent of the senior citizen who were tested showed a dramatic improvement in their moods and their attitudes toward life in general.19

A study was conducted on back massage and similar technique to promote sleep in elderly people It states that insomnia is a frequent problem among elderly people. As aconsequence, sedative hypnotic drugs are prescribed very often that can lead to problamaticeffects.as an alternative to sedative hypnotic drugs nurses use relaxing interventions to promote sleep. One of these techniques, the back massage, is very popular because of the expected relaxing effect of touch. gains this back ground ,this review includes 16 surveys of the international nursing literature and the German literature, that analyze the most

9 common intervention in Germany “Atemstimulierende Einreibung”,similar to effleurage. These studies are presented and evaluated. The results indicated that these interventions promote relaxation and sleep and that they are perceived as very pleasant by the elderly.20

A study was conducted on application of The Shuler Nurse

Practitioner Practice Model with elderly patients through use of a gerontological wholistic assessment and the utilization of the model in developing a treatment plan and evaluating patient outcomes. Selected literature from nursing and medicine, including natural, alternative, and complementary (NAC) therapies, as well as the authors' personal experiences. The literature concluded that providing health care services to the elderly involves recognition of not only physical ailments, but also an awareness of how functional status, psychological condition, social support, environmental conditions and cultural, as well as spiritual beliefs, shape the total health care needs of this vulnerable group. Nurse practitioners who work with the aged could benefit from a theoretically based, wholistic assessment guide. Treatment plans that include NAC therapies and healing strategies should be considered. Outcome evaluations should reflect adherence to the elders' preferences regarding quality and end-of-life issues.21

A study was conducted on examine the feasibility of implementing specific nursing interventions to promote sleep in hospitalized older adults. The experimental group received a sleep protocol intervention while the control group received usual night time care. While no differences were noted in sleep quality and duration between groups, the experimental group experienced better sleep quality (P = .001), ability to remain asleep (P = .018) and used fewer sleep

10 medications than the control group (P = .044). In addition, those taking sleep medications experienced more awakenings and fewer sleep hours. Experimental group patients identified preferences such as personal hygiene, awareness of normal bedtime, receiving a back rub, straightening bed linens, and receiving a bedtime snack. This pilot provides initial support for the feasibility and utility of implementing a sleep protocol in an acute care setting.22

The daily stress and strain of life takes a huge toll on our bodies. Result- aching backs, stiff neck and painful shoulders. Getting a massage done is one of the best ways of relaxing and rejuvenating your self. Back massage is a great way of getting rid of back aches as massage helps in relaxation and increased circulation. The best way is to get a back massage done. Get it done from a professional. Here are some helpful tips. While getting a back massage, you need to lie down flat on your belly on a comfortable surface like a floor mat or firm bed. Usually oils are used for back massage to decrease friction on the skin.

However, according to experts, less quantity of oil application leads to greater friction and pressure. The back massage begins at the spine, starts at the lower back area and slowly moves towards the shoulders. Massage also helps in treatment of insomnia along with aiding in providing relief from chronic pain.23

6.3 STATEMENT OF THE PROBLEM

“ A QUASI EXPERIMENTAL STUDY TO EVALUATE THE

EFFECTIVENESS OF THERAPEUTIC BACK MASSAGE ON QUALITY

OF SLEEP AMONG THE ELDERLY BEDRIDDEN IN SELECTED

HOSPITALS OF BANGALORE”

11 6.4 OBJECTIVES OF THE STUDY

1. Assess the pre test level of sleep in both experimental and control

group.

2. Administer therapeutic back massage in experimental group.

3. Evaluate the effectiveness of therapeutic back massage by

comparing the pre test and post test level of sleep in both

experimental and control group.

4. Associate the post test level of sleep with selected socio

demographic variable. 6.5 OPERATIONAL DEFINITION

1. EVALUTE: Measure the level of sleep before and after the therapeutic back massage

2. EFFECTIVENESS: Outcome of the intervention measured in terms of increased in numerical scores.

3. THERAPEUTIC BACK MASSAGE: The one of the type of therapy in this therapist using the fingers to rub and massage the back with four steps such as circular massage ,effleurage, pettisarge and kneading.

4. QUALITY OF SLEEP – A periodic state of rest accompanied by varying degree of unconsciousness and relative inactivity which measured through the scale prepared by the researcher.

5. ELDERLY BEDRIDDEN

Those who are falls on the age group of 60 years and above and unable to move from the bed due to their health condition. 6.6 ASSUMPTIONS

12 1 Therapeutic back massage promote sense of well being of the bedridden

patient

2. Therapeutic back massage reduce the pain and discomfort of the

bedridden patients

3. Elderly bedridden may have sleep disturbances and decreased sleep 6.7 DELIMITATIONS

1. The sample size is limited to 60 elderly bedridden Patients

2. Prescribed data collection period is only 4 to 6 wks

6.8 HYPOTHESIS

H1: There is a significant increase in the level of sleep after the

administration of therapeutic back massage than before in the

experimental group

7. MATERIALS AND METHODS

7.1 SOURCE OF DATA

. Elderly those who are living in the selected areas of Bangalore

13 7.1.1 RESEARCH DESIGN

The research design adopted for the study was quasi experimental

(two group pre test and post test) with manipulation no randomization and control group.

Experiment

al group O1 X O2 Control

group O1 …….. O2

O1-Pretest level of sleep

O2-Posttest level of sleep

X- Intervention- therapeutic back massage 7.1.2 SETTING

The study will be conducted in selected hospitals of Bangalore.

7.1.3 POPULATION

Elderly people those who are admitted in the selected hospitals of Bangalore

CONCEPTUAL FRAMEWORK:

The conceptual frame work of the study based on the Roy’s adaptation

7.2 METHOD OF DATA COLLECTION

7.2.1 SAMPLING PROCEDURE

Non Probability – convenient sampling

7.2.2 SAMPLE SIZE

Sample comprises of 60 elderly bedridden Patients. Thirty in experimental

14 group and thirty in control group

7.2.3 INCLUSION CRITERIA FOR SAMPLING

1. Samples are elderly people admitted in selected Hospitals of

Bangalore.

2. Those who can able to understand the Kannada.and English.

3. Those who are willing to participate in the study.

4. Both male and female elderly person those who are in an age of

above 60.

5. Elderly bed ridden patients those who admitted in selected hospital of

Bangalore.

7.2.4 EXCLUSION CRITERIA FOR SAMPLING.

1. Those who are absent during the period of study.

2. Those who are in critical condition.

3. Those who are using any sleep inducing medicines.

4. Those who are in unconscious state.

7.2.5 INSTRUMENTS INTENDED TO BE USED

This instrument has two parts. Part A consist of

sociodemographic variables of sample, Part B consist of sleep self

instructed rating scale which is prepared by the researcher indented to be

used in the study.

7.2.6 DATA COLLECTION METHOD

Sleep Self instructed rating scale will be used to collect the data.

7.2.7 PLAN FOR DATA ANALYSIS

15 The data analysis planned for the descriptive statistics and inferential

statistics. The descriptive statistics plan to use in data analysis are the

percentage, mean and standard deviation and inferential statistics are paired

‘t’ test and chi square test ETHICAL CONSIDERATION

7.3 Does the study require any intervention to be provided to the elderly? Yes.

7.4 Has ethical clearances being obtained from institution?

7.5Have you concerned for the hospital authority?

16 LIST OF REFERENCES

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8 Srivastava RK. Multicentric study to establish epidemiological data on

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14 Jennifer Kanady .Decreased Total Sleep Time Associated with

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16 Lankford DA, Corser BC, Zheng YP et al. Effect of Gaboxadol on

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17 Zgierska A, Brown RT, Zuelsdorff M.Sleep and daytime sleepiness

problems among patients with chronic non cancerous pain receiving long-

term opioid therapy: a cross-sectional study. J Opioid Manag. 2007 Nov-

Dec;3 (6):317-27.

18 Walsh JK, Krystal AD, Amato D A .et al Nightly treatment of primary

insomnia with Eszopiclone for six months: effect on sleep, quality of life,

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21 Pamela A. Shuler Roxana Huebscher and Judith Hallock Providing

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Practitioners. Volume 13 Issue 7, Pages 297 - 303 Published Online:

24 May 2005

19 22 R. Lareau, L. Benson, K. Watcharotone, G. Manguba .Examining the

Feasibility of Implementing Specific Nursing Interventions to Promote

Sleep in Hospitalized Elderly Patients. Geriatric Nursing, Volume 29,

Issue 3, Pages 197-206: 2005 www.elsiever.com

23 Benefits and techniques of back massagewww.ayushveda.com/.../back-

massage-benefits-and-techniques27: Jan 2009.

20 21 8. Signature of the candidate

9. Remarks of the guide

10. Name and designation of (in block letters)

10.1 Guide

10.2 Signature

10.3 Co-guide (if any) .

10.4 Signature

11 11.1 Head of the department

11.2 Signature

12. 12.1 Remarks of the Chairman and Principal

12.2 Signature