Palliative CareNCT05168514
The Effect of Back Massage on Palliative Care Patients on Sleep Quality and Pain
A study testing Massage in people with Palliative Care, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to evaluate the effect of back massage applied to palliative care patients on sleep quality and pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care
- What is being tested?
- Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2021to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study was planned to evaluate the effect of back massage applied to palliative care patients on sleep quality and pain.
Read the 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.
- Conditions
- Palliative Care
- Being tested
- Massage
- Keywords
- back massage, Palliative care, nursing care, massage practice, pain, sleep quality
- Medical subject headings
- Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
"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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start15 Dec 2021
- Primary completion30 Jun 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevil PAMUK CEBECİ, Eskisehir Osmangazi University
- Investigators
- Sevil PAMUK CEBECİ, Study director, sevil.pamukcebeci@ogu.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168514
- Sponsor's protocol ID
- 2021-2
- Status last verified
- Aug 2022
- First submitted
- 9 Dec 2021
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Back Massage on Palliative Care Patients on Sleep Quality and Pain
- ClinicalTrials.gov ID
- NCT05168514
- Acronym / sponsor ID
- 2021-2
- Conditions
- Palliative Care
- Keywords
- back massage, Palliative care, nursing care, massage practice, pain, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Other: MassageMassage 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage"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. | Other | Massage |
Primary outcome
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.
Time frame: 10 weeks
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.
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".
Time frame: 10 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevil PAMUK CEBECİ study director
sevil.pamukcebeci@ogu.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage in people with Palliative Care, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.