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Investigation of the Effect of Abdominal Massage Applied to Palliative Care Patients on Constipation and Quality of Life

Primary Purpose

MASSAGE

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ABDOMINAL MASSAGE APPLICATION
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for MASSAGE focused on measuring Abdominal massage, Palliative care, Constipation, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Inclusion criteria for the first phase of the study; 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, 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. Exclusion Criteria: Exclusion criteria for the first phase of the study; 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. Exclusion criteria for the second phase of the study; 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 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.

Sites / Locations

  • Sevil PAMUK CEBECİ
  • Eskişehir Şehir Hastanesi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Massage

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2022
Last Updated
September 11, 2023
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05742672
Brief Title
Investigation of the Effect of Abdominal Massage Applied to Palliative Care Patients on Constipation and Quality of Life
Official Title
Investigation of the Effect of Abdominal Massage Applied to Palliative Care Patients on Constipation and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MASSAGE
Keywords
Abdominal massage, Palliative care, Constipation, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Massage
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ABDOMINAL MASSAGE APPLICATION
Intervention Description
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.
Primary Outcome Measure Information:
Title
To accept the hypothesis that the application of abdominal massage to palliative care patients has an effect on constipation.
Description
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.
Time Frame
1 weeks
Title
To accept the hypothesis that the application of abdominal massage to palliative care patients has an impact on quality of life.
Description
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.
Time Frame
1 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for the first phase of the study; 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, 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. Exclusion Criteria: Exclusion criteria for the first phase of the study; 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. Exclusion criteria for the second phase of the study; 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevil PAMUK CEBECİ, Asst.Prof.
Organizational Affiliation
sevil.pamukcebeci@ogu.edu.tr
Official's Role
Study Director
Facility Information:
Facility Name
Sevil PAMUK CEBECİ
City
Eskişehir
State/Province
Eskisehir
ZIP/Postal Code
26020
Country
Turkey
Facility Name
Eskişehir Şehir Hastanesi
City
Eskişehir
ZIP/Postal Code
26020
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Investigation of the Effect of Abdominal Massage Applied to Palliative Care Patients on Constipation and Quality of Life

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