Clinical trial NCT05168514: The Effect of Back Massage on Palliative Care Patients on Sleep Quality and Pain
Official title: The Effect of Back Massage on Palliative Care Patients on Sleep Quality and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: back massage
Palliative care
nursing care
massage practice
pain
sleep quality
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed description: The most common complaint in palliative care patients is pain. Therefore, the quality of palliative care is demonstrated by the good management of patients' pain and suffering. In the treatment of pain, pharmacological and non-pharmacological treatments should be used together. As a result of the relaxation of the muscles with massage, which is one of the non-pharmacological treatments, the pain is relieved and reduced. Again, massage increases the release of endorphins and reduces the feeling of pain. Another common complaint in palliative care patients is insomnia. Sleep quality is also linked to pain. Low sleep quality causes a decrease in tolerance to pain, more drugs are used to relieve pain, and a negative cycle is formed by affecting sleep quality. Massage is one of the oldest treatment methods used to relieve many ailments. Florence Nightingale described massage in her Notes on Nursing published in 1859 and provided its use in the field of nursing.

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

The study was planned as a randomized controlled experimental study between November 2021 and June 2022. Patients hospitalized in the Palliative Care Service of Bilecik Training and Research Hospital, the sample will be 52 patients, 26 patients in each group, with a 95% CI 90% power, as a result of the calculation made using the G\*Power 3.1.9.7 program. Written consent will be obtained from the patients who agree to participate in the study and the "Patient Identification Form" will be filled. Back massage will be applied to the experimental group for 10 minutes every day for 7 days. Pittsburgh Sleep Quality Index, McGill Pain Scale Short Form will be administered after each massage and scores will be recorded for 7 days. Scales and massage will be applied to the patients before the administration of the pharmacological agent, which is among the routine treatment and care practices in the clinic. 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 will be applied to the control group simultaneously with the experimental group and scores will be recorded for 7 days. The obtained data will be evaluated using appropriate statistical methods.

As a result of the research, it is thought that the questions of whether there is a significant difference in sleep quality and pain scale between the patient group who received back massage in palliative care and the patient group who did not receive it will be answered.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: 10 weeks
measure: 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".
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bilecik
country: Turkey
facility: Bilecik Devlet Hastanesi
Study officials:
affiliation: sevil.pamukcebeci@ogu.edu.tr
name: Sevil PAMUK CEBECİ
role: STUDY_DIRECTOR
References: