The Effect of Back Massage on Palliative Care Patients on Sleep Quality and Pain

NCT05168514 | Completed DMC

• 1 other identifier: 2021-2
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to evaluate the effect of back massage applied to palliative care patients on sleep quality and pain.

Conditions

Palliative Care

Keywords

back massage; Palliative care; nursing care; massage practice; pain; sleep quality

Outcome Measures

Primary Outcomes (2)

• To accept the hypothesis that there is a significant difference between the sleep quality mean scores of the experimental group and the sleep quality mean scores of the control group in palliative care patients.

  The Pittsburgh Sleep Quality Index (PUKI) will be used to measure the effect of back massage applied to the experimental group on sleep quality. PUKI is a 19-item scale that evaluates sleep quality and disorder. Each item of the test is scored between 0-3. The scale consists of 7 subscales that assess subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleep medication, and loss of daytime functionality. By summing up the subscales, a total PUKI score ranging from 0 to 21 is obtained. A total PSQI score greater than five, with 89.6% sensitivity and 86.5% specificity, indicates inadequate sleep quality and indicates severe impairment in at least two areas or moderate impairment in three areas.

  10 weeks

• To accept the hypothesis that "there is a significant difference between the mean pain score of the experimental group and the pain score of the control group in palliative care patients".

  The scale consists of three parts; first part; 11 of them evaluate the sensory and 4 of them evaluate the perceptual dimension of the pain. These descriptors are rated on an intensity scale from 0 to 3 (0= none, 1= mild, 2= moderate, 3= excessive). In the first part of the scale, a total of three pain scores are obtained: sensory pain score, perceptual pain score and total pain score. The sensory pain score is between 0-33, the perceptual pain score is between 0-12, and the total pain score is between 0-45. The increase in the score indicates that the pain also increased. Part Two: There were five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of the patient's pain. Part Three: The patient's current pain intensity was assessed using a visual comparison scale.

  10 weeks

Study Arms (1)

Massage

EXPERIMENTAL

Massage begins with the patting (eflorage) maneuver. Massage is continued with petrissage, bearing, friction and percussion maneuvers. Maneuvers are performed for 3-5 minutes. A patting motion is performed between maneuvers and at the end of the massage. During the massage, it is observed whether the integrity of the skin is impaired or in terms of redness.

Other: Massage

Interventions

Massage OTHER

"Patient Identification Form", "Pittsburgh Sleep Quality Index" and "McGill Pain Scale Short Form" will be applied to patients with written and verbal consent. Scales and massage application will be done before the pharmacological agent is administered to the patients. Back massage will be applied to the experimental group for 10 minutes every day for 10 days. Routine treatment and care practices in the clinic will continue. "Pittsburgh Sleep Quality Index", "McGill Pain Scale Short Form" will be applied to the experimental group before and after each massage and scores will be recorded for 10 days. The control group will not be interfered with, and the routine treatment and care practices in the clinic will continue. "Pittsburgh Sleep Quality Index", "McGill Pain Scale Short Form" will be applied to the control group simultaneously with the experimental group and scores will be recorded for 10 days.

Massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least literate education level,
• Having no cognitive, affective and verbal communication problems that would prevent the understanding of the given information and the ability to accurately express pain and sleep,
• Over 18 years old,
• Being in the palliative service,
• Patients who do not react negatively to any attempt to touch, such as massage,
• Patients with full and healthy tissue integrity in the area to be massaged.

You may not qualify if:

• İlliterate to read and write
• Having any cognitive, affective and verbal communication problems that prevent the understanding of the given information and the ability to accurately express pain and sleep,
• Under the age of 18,
• Reacts negatively to any attempt to touch, such as massage,
• Patients whose tissue integrity is not complete and healthy in the area to be massaged.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Bilecik Devlet Hastanesi

Bilecik, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Sleep Initiation and Maintenance Disorders

Interventions

Massage

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Sevil PAMUK CEBECİ

  sevil.pamukcebeci@ogu.edu.tr

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Single-blind randomized control method will be used in the study, patients in the experimental and control groups will not know which group they are in. Randomization Method: Experimental and control groups will be determined from patients who meet the sampling selection criteria, using the Random Integer Generator method from the random.org site, Numbersalt.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof.Dr.

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 23, 2021
• Study Start: December 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 15, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)