MASSAGENCT05742672
Investigation of the Effect of Abdominal Massage Applied to Palliative Care Patients on Constipation and Quality of Life
A study testing ABDOMINAL MASSAGE APPLICATION in people with MASSAGE, run by Eskisehir Osmangazi University at 2 sites in Turkey (Türkiye).
Trial summary
The problem of constipation plays a very important role among these symptoms that patients experience intensely and negatively affect their quality of life. Although constipation is not a disease, it is a condition that causes discomfort to the person and may develop due to idiopathic reasons, as well as depending on… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- MASSAGE
- What is being tested?
- ABDOMINAL MASSAGE APPLICATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 30 Jun 2023
- 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
- A first-degree relative or volunteer to participate in the research approved to participate in the research by
- 18 years and over,
- Patients receiving inpatient treatment and care in the palliative care service. Inclusion criteria for the second phase of the study;
- A first-degree relative or volunteer to participate in the research approved to participate in the research by
- Having at least 2 or more of the Rome III constipation diagnostic criteria,
- Constipation Severity Scale score is 25 and above,
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- No intestinal obstruction
- No radiotherapy or surgery was applied to the abdominal region until six weeks ago,
- Does not have diarrhea,
- Patients who do not have abdominal massage application restrictions.
Who cannot join
- Those who do not volunteer to participate in the research or who are not approved to participate in the research by their first-degree relatives,
- under the age of 18,
- Patients who do not receive inpatient treatment and care in the palliative care service.
- Those who do not volunteer to participate in the research or who are not approved to participate in the research by their first-degree relatives,
- Below 2 of the Rome III constipation diagnostic criteria
- Constipation Severity Scale score below 25 points
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- Intestinal obstruction
- Radiotherapy or surgery was applied to the abdominal region up to six weeks ago,
- Having diarrhea
- Patients with abdominal massage application restrictions will be formed.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Sevil PAMUK CEBECİ
Eskişehir, Eskişehir, 26020
Eskişehir Şehir Hastanesi
Eskişehir, 26020
About this study
The problem of constipation plays a very important role among these symptoms that patients experience intensely and negatively affect their quality of life. Although constipation is not a disease, it is a condition that causes discomfort to the person and may develop due to idiopathic reasons, as well as depending on diet, exercise habits, medications used and various disease processes. It may also occur. Constipation is one of the most common symptoms in patients treated in palliative care, and its prevalence is thought to be approximately 30-90%. Constipation is the third most common problem in palliative care, after pain and loss of appetite. Although drug therapy is the first method that comes to mind in the treatment of constipation, as it is known, medical treatment has many side effects risks and long-term drug use causes health problems. It creates a high financial burden on the care system. The high side effects and costs of laxative drugs used in the management of constipation necessitate the use of non-pharmacological methods. Non-pharmacological methods used in the management of constipation generally include regular exercise, fluid intake, and increased consumption of fiber foods. One of them is the abdominal massage method. The number of studies on the effects of abdominal massage in the Palliative Care patient group, who frequently experience constipation, is very limited in the literature. For these reasons, the study was planned to examine the effect of abdominal massage applied to palliative care patients on constipation and quality of life.
Read the detailed description
The problem of constipation plays a very important role among these symptoms that patients experience intensely and negatively affect their quality of life. Although constipation is not a disease, it is a condition that causes discomfort to the person and may develop due to idiopathic reasons, as well as depending on diet, exercise habits, medications used and various disease processes. It may also occur. Constipation is one of the most common symptoms in patients treated in palliative care, and its prevalence is thought to be approximately 30-90%. Constipation is the third most common problem in palliative care, after pain and loss of appetite. Although drug therapy is the first method that comes to mind in the treatment of constipation, as it is known, medical treatment has many side effects risks and long-term drug use causes health problems. It creates a high financial burden on the care system. The high side effects and costs of laxative drugs used in the management of constipation necessitate the use of non-pharmacological methods. Non-pharmacological methods used in the management of constipation generally include regular exercise, fluid intake, and increased consumption of fiber foods. One of them is the abdominal massage method. The number of studies on the effects of abdominal massage in the Palliative Care patient group, who frequently experience constipation, is very limited in the literature. For these reasons, the study was planned to examine the effect of abdominal massage applied to palliative care patients on constipation and quality of life.Abdominal massage applied to palliative care patients It was planned in two stages to determine its effect on constipation and quality of life. The first phase of the study was descriptive and cross-sectional, and the second phase was planned as a randomized experimental study with a pretest-post test control group design.
In the first phase of the research, answers to the following questions will be sought.
What is the severity of constipation in palliative care patients?
-Performing daily living activities of palliative care patients How is the dependency independence situation?
Hypotheses of the Research:
H1: The application of abdominal massage to palliative care patients has an effect on constipation.
H1: The application of abdominal massage to palliative care patients has a positive effect on the quality of life.
The independent variable of the study was abdominal massage application, and the dependent variables were constipation and quality of life levels of palliative care patients.
- Conditions
- MASSAGE
- Being tested
- ABDOMINAL MASSAGE APPLICATION
- Keywords
- Abdominal massage, Palliative care, Constipation, Quality of Life
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABDOMINAL MASSAGE APPLICATIONOther
- Experiment group twice a day in the morning and evening and 30 minutes after the feeding meal, for 15 minutes. For a period of time, effusion, petrissage, vibration massage movements will be applied by the researcher in accordance with the procedure (Abdominal Massage Application Directive). The application will continue for 7 days.- On the 3rd day (short term), 5th day (mid term) and 7th day (long term) to the massaged experimental group, the Constipation Severity Scale (CQS) and the Constipation Quality of Life Scale (QQQL) will be administered to determine the effect.
- Day 7 Rome Ш Constipation Diagnostic Criteria (Annex: 2) will be applied again and the patient's constipation status will be evaluated for the last time.
- Routine treatment and care practices in the clinic will continue.
| Study group | Role | What they receive |
|---|---|---|
| Massage | Experimental | In the experimental group, twice a day, in the morning and evening, and 30 minutes after the meal, for 15 minutes. Effusion, petrissage and vibration massage movements will be applied by the researcher for a certain period of time in accordance with the procedure (Abdominal Massage Application Directive). The application will continue for 7 days. Receives: Other: ABDOMINAL MASSAGE APPLICATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
To accept the hypothesis that the application of abdominal massage to palliative care patients has an effect on constipation.
Constipation Severity Scale (CSS) will be used to measure the effect of abdominal massage applied to the experimental group on constipation. There are 16 questions in the scale. The Constipation Severity Scale has three sub-dimensions: Stool Obstruction, Large Intestine Laziness, and Pain. The score that can be taken from the stool obstruction sub-dimension is 0-28, the score that can be taken from the large intestine laziness sub-dimension is between 0-29, and the score that can be taken from the pain sub-dimension is between 0-16. The lowest total score that can be obtained from the scale is 0, and the highest is 73. A high score on the scale indicates that the symptoms are serious.
Measured: 1 weeks
To accept the hypothesis that the application of abdominal massage to palliative care patients has an impact on quality of life.
Constipation Quality of Life Scale, the scale developed to determine the effect of constipation on quality of life, consists of "worry/anxiety" (11 items), "physical discomfort" (4 items), "psychosocial discomfort" (8 items), "satisfaction" (5 items) subscales. consists of scales. The scale consists of 28 items in total. The highest score that can be obtained from the five-point Likert scale is 140, and the lowest score is 28. As the scores obtained from the scale increase, it is thought that the quality of life is negatively affected.
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Dec 2022
- Primary completion30 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASSAGEStudies 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
- Supportive care
- 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, Asst.Prof., Study director, sevil.pamukcebeci@ogu.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742672
- Sponsor's protocol ID
- 2022-3
- Status last verified
- Sep 2023
- First submitted
- 19 Dec 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- 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 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Abdominal Massage Applied to Palliative Care Patients on Constipation and Quality of Life
- ClinicalTrials.gov ID
- NCT05742672
- Acronym / sponsor ID
- 2022-3
- Conditions
- MASSAGE
- Keywords
- Abdominal massage, Palliative care, Constipation, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 24 Feb 2023 (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.
The problem of constipation plays a very important role among these symptoms that patients experience intensely and negatively affect their quality of life. Although constipation is not a disease, it is a condition that causes discomfort to the person and may develop due to idiopathic reasons, as well as depending on diet, exercise habits, medications used and various disease processes. It may also occur. Constipation is one of the most common symptoms in patients treated in palliative care, and its prevalence is thought to be approximately 30-90%. Constipation is the third most common problem in palliative care, after pain and loss of appetite. Although drug therapy is the first method that comes to mind in the treatment of constipation, as it is known, medical treatment has many side effects risks and long-term drug use causes health problems. It creates a high financial burden on the care system. The high side effects and costs of laxative drugs used in the management of constipation necessitate the use of non-pharmacological methods. Non-pharmacological methods used in the management of constipation generally include regular exercise, fluid intake, and increased consumption of fiber foods. One of them is the abdominal massage method. The number of studies on the effects of abdominal massage in the Palliative Care patient group, who frequently experience constipation, is very limited in the literature. For these reasons, the study was planned to examine the effect of abdominal massage applied to palliative care patients on constipation and quality of life.
Detailed description
The problem of constipation plays a very important role among these symptoms that patients experience intensely and negatively affect their quality of life. Although constipation is not a disease, it is a condition that causes discomfort to the person and may develop due to idiopathic reasons, as well as depending on diet, exercise habits, medications used and various disease processes. It may also occur. Constipation is one of the most common symptoms in patients treated in palliative care, and its prevalence is thought to be approximately 30-90%. Constipation is the third most common problem in palliative care, after pain and loss of appetite. Although drug therapy is the first method that comes to mind in the treatment of constipation, as it is known, medical treatment has many side effects risks and long-term drug use causes health problems. It creates a high financial burden on the care system. The high side effects and costs of laxative drugs used in the management of constipation necessitate the use of non-pharmacological methods. Non-pharmacological methods used in the management of constipation generally include regular exercise, fluid intake, and increased consumption of fiber foods. One of them is the abdominal massage method. The number of studies on the effects of abdominal massage in the Palliative Care patient group, who frequently experience constipation, is very limited in the literature. For these reasons, the study was planned to examine the effect of abdominal massage applied to palliative care patients on constipation and quality of life.Abdominal massage applied to palliative care patients It was planned in two stages to determine its effect on constipation and quality of life. The first phase of the study was descriptive and cross-sectional, and the second phase was planned as a randomized experimental study with a pretest-post test control group design.
In the first phase of the research, answers to the following questions will be sought.
What is the severity of constipation in palliative care patients?
-Performing daily living activities of palliative care patients How is the dependency independence situation?
Hypotheses of the Research:
H1: The application of abdominal massage to palliative care patients has an effect on constipation.
H1: The application of abdominal massage to palliative care patients has a positive effect on the quality of life.
The independent variable of the study was abdominal massage application, and the dependent variables were constipation and quality of life levels of palliative care patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Other: ABDOMINAL MASSAGE APPLICATIONIn the experimental group, twice a day, in the morning and evening, and 30 minutes after the meal, for 15 minutes. Effusion, petrissage and vibration massage movements will be applied by the researcher for a certain period of time in accordance with the procedure (Abdominal Massage Application Directive). The application will continue for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A first-degree relative or volunteer to participate in the research approved to participate in the research by
- 18 years and over,
- Patients receiving inpatient treatment and care in the palliative care service. Inclusion criteria for the second phase of the study;
- A first-degree relative or volunteer to participate in the research approved to participate in the research by
- Having at least 2 or more of the Rome III constipation diagnostic criteria,
Key exclusion criteria (10 listed)
- Those who do not volunteer to participate in the research or who are not approved to participate in the research by their first-degree relatives,
- under the age of 18,
- Patients who do not receive inpatient treatment and care in the palliative care service.
- Those who do not volunteer to participate in the research or who are not approved to participate in the research by their first-degree relatives,
- Below 2 of the Rome III constipation diagnostic criteria
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 |
|---|---|---|
| ABDOMINAL MASSAGE APPLICATION* Experiment group twice a day in the morning and evening and 30 minutes after the feeding meal, for 15 minutes. For a period of time, effusion, petrissage, vibration massage movements will be applied by the researcher in accordance with the procedure (Abdominal Massage Application Directive). The application will continue for 7 days.- On the 3rd day (short term), 5th day (mid term) and 7th day (long term) to the massaged experimental group, the Constipation Severity Scale (CQS) and the Constipation Quality of Life Scale (QQQL) will be administered to determine the effect. * Day 7 Rome Ш Constipation Diagnostic Criteria (Annex: 2) will be applied again and the patient's constipation status will be evaluated for the last time. * Routine treatment and care practices in the clinic will continue. | Other | Massage |
Primary outcome
To accept the hypothesis that the application of abdominal massage to palliative care patients has an effect on constipation.
Time frame: 1 weeks
Constipation Severity Scale (CSS) will be used to measure the effect of abdominal massage applied to the experimental group on constipation. There are 16 questions in the scale. The Constipation Severity Scale has three sub-dimensions: Stool Obstruction, Large Intestine Laziness, and Pain. The score that can be taken from the stool obstruction sub-dimension is 0-28, the score that can be taken from the large intestine laziness sub-dimension is between 0-29, and the score that can be taken from the pain sub-dimension is between 0-16. The lowest total score that can be obtained from the scale is 0, and the highest is 73. A high score on the scale indicates that the symptoms are serious.
To accept the hypothesis that the application of abdominal massage to palliative care patients has an impact on quality of life.
Time frame: 1 weeks
Constipation Quality of Life Scale, the scale developed to determine the effect of constipation on quality of life, consists of "worry/anxiety" (11 items), "physical discomfort" (4 items), "psychosocial discomfort" (8 items), "satisfaction" (5 items) subscales. consists of scales. The scale consists of 28 items in total. The highest score that can be obtained from the five-point Likert scale is 140, and the lowest score is 28. As the scores obtained from the scale increase, it is thought that the quality of life is negatively affected.
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 13 Sep 2023.
- 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, Asst.Prof. study director
sevil.pamukcebeci@ogu.edu.tr
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABDOMINAL MASSAGE APPLICATION in people with MASSAGE, run by Eskisehir Osmangazi University at 2 sites 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 10 inclusion and 10 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 the application of abdominal massage to palliative care patients has an effect on constipation. (time frame: 1 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 13 Sep 2023.