Effect of Abdominal Massage on Palliative Care Patients
Primary Purpose
Constipation, Abdominal Pain, Palliative Care
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Abdominal massage
Sponsored by
About this trial
This is an interventional supportive care trial for Constipation focused on measuring palliative, palliative care, nursing, abdominal massage, constipation
Eligibility Criteria
Inclusion Criteria:
- Volunteering
- Being over 18 years old
- No history of gastrointestinal cancer, history of abdominal surgery or abdominal hernia
- At least 7 days of clinical treatment
Exclusion Criteria:
- Patient information form
- Gastrointestinal system rating scale
- Constipation assessment scale
- Bristol stool consistency scale
Sites / Locations
- Özge Uçar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Abdominal massage group
Standart care group
Arm Description
Abdominal massage using for evaluation of constipation.
No intervention palliative care patient
Outcomes
Primary Outcome Measures
First measurements of defecation type.
First measurements of both group before intervention using by Bristol Stool Consistency Scale. The Bristol Stool Consistency Scale, developed by a team of gastroenterologists at the University of Bristol, UK; It is used to evaluate stool form and to have information about changes in bowel habits and a pathological formation that may occur in the intestine. This scale was designed to classify an individual's bowel movements in seven distinct categories of stool. According to the Bristol Stool Consistency Scale, Type 1 and Type 2 are constipation, Type 3 and Type 4 are normal stools, and Type 5, Type 6 and Type 7 are diarrhea. It is accepted that there is a direct relationship between stool shape and length of stay in the colon (Lewis and Heaton 1997).
First measurements of gastrointestinal symptoms
First measurements of both groups before the intervention using a Gastrointestinal Symptom Rating Scale.The Turkish validity and reliability of the scale, which was developed by Revicki et al. in 1998 to evaluate the symptoms frequently seen in gastrointestinal system disorders, was performed by Turan and Aştı in 2011. GSRS; It is a 15-item Likert-type scale with options starting from "no discomfort" to "very severe discomfort". Based on factor analysis, 15 items of the GSRS have five sub-dimensions: Abdominal Pain, Reflux, Diarrhea, Indigestion and Constipation. In the GSRS, how the individual felt in terms of gastrointestinal problems in the last week is questioned. High scores on the GSRS indicate that the symptoms are more severe (Revicki et al. 1998; Kaya and Turan 2011; Turan and Aştı 2011).
Secondary Outcome Measures
Full Information
NCT ID
NCT05580679
First Posted
October 7, 2022
Last Updated
September 17, 2023
Sponsor
Bartın Unıversity
Collaborators
The Scientific and Technological Research Council of Turkey
1. Study Identification
Unique Protocol Identification Number
NCT05580679
Brief Title
Effect of Abdominal Massage on Palliative Care Patients
Official Title
The Effect of Abdominal Massage on Managing Constipation in Palliative Care Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bartın Unıversity
Collaborators
The Scientific and Technological Research Council of Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Constipation is defined as infrequent defecation or difficulty in evacuation. Although the constipation problem is mostly self-managed by the patients, 22% mostly refer to primary health care providers (>50%), resulting in large expenditures for diagnostic tests and treatments. According to studies conducted in our country, the incidence of constipation varies between 22-40%, while it is stated that the prevalence of constipation in hospitalized patients is 79%. Annual medical costs due to constipation are estimated to exceed 230 million dollars. Pharmacological and non-pharmacological methods are used in the management of constipation, which is one of the most common symptoms in the hospital. The use of non-pharmacological methods is recommended due to the possibility of side effects and cost of pharmacological methods. However, the prevalence of use of non-pharmacological methods in the clinic is low. Nurses need to have knowledge about non-pharmacological methods in order to manage the problem of constipation, which is one of the most common symptoms in the hospital. Abdominal massage, which is included in the Nursing Interventions Classification (NIC), is an application performed with manipulations such as pressure and rubbing on certain points on the body to reduce pain, provide relaxation and relaxation, prevent and reduce nausea, and prevent constipation.
Detailed Description
Introduction: Constipation is defined as infrequent defecation or difficulty in evacuation. Although the constipation problem is mostly self-managed by the patients, 22% mostly refer to primary health care providers (>50%), resulting in large expenditures for diagnostic tests and treatments. According to studies conducted in our country, the incidence of constipation varies between 22-40%, while it is stated that the prevalence of constipation in hospitalized patients is 79%. Annual medical costs due to constipation are estimated to exceed 230 million dollars. Pharmacological and non-pharmacological methods are used in the management of constipation, which is one of the most common symptoms in the hospital. The use of non-pharmacological methods is recommended due to the possibility of side effects and cost of pharmacological methods. However, the prevalence of use of non-pharmacological methods in the clinic is low. Nurses need to have knowledge about non-pharmacological methods in order to manage the problem of constipation, which is one of the most common symptoms in the hospital. Abdominal massage, which is included in the Nursing Interventions Classification (NIC), is an application performed with manipulations such as pressure and rubbing on certain points on the body to reduce pain, provide relaxation and relaxation, prevent and reduce nausea, and prevent constipation.
Objective: This study was planned to examine the effect of abdominal massage on the management of constipation in palliative care patients.
Method: The project will be carried out in a state hospital in Bartın, between 01.09.2021 and 01.09.2022, in the palliative care service, with patients over 18 years of age, without a history of gastrointestinal cancer, history of abdominal surgery or abdominal hernia, and hospitalized for at least 7 days. Palliative care patients hospitalized in Bartın State Hospital in the last 1 year will form the universe. Sample calculation will be made with G power analysis and the participants will be divided into experimental and control groups with block randomization. The patients in the experimental group will be given abdominal massage in the morning and evening every day for 1 week and the defecation status of the patients will be compared. The data will be recorded in the data collection form prepared in line with the literature. The data will be used in the patient identification form, Gastrointestinal Symptom Rating Scale, Constipation Evaluation Scale, Bristol Stool Consistency Scale. The collected data will be evaluated using the SPSS program.
Conclusion: With this project, the incidence of constipation in palliative patients will be determined and the knowledge and skills of nursing students on how to apply abdominal massage, which is one of the nursing practices, will increase. With their practice in this study, they will play an active role in the management of constipation in palliative patients, and they will be able to perform this practice in patients in various services throughout their education and professional lives.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Abdominal Pain, Palliative Care
Keywords
palliative, palliative care, nursing, abdominal massage, constipation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized Controlled Trials
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abdominal massage group
Arm Type
Experimental
Arm Description
Abdominal massage using for evaluation of constipation.
Arm Title
Standart care group
Arm Type
No Intervention
Arm Description
No intervention palliative care patient
Intervention Type
Other
Intervention Name(s)
Abdominal massage
Intervention Description
Application time of the massage: 30 minutes after meals, twice a day, at 10:00 in the morning and at 16:00 in the evening.
Application time of the massage: 15 minutes each Materials needed: Gloves, Liquid Vaseline, Paper Towel Massage methods used: Efflorage, Petrissage, Vibration
Primary Outcome Measure Information:
Title
First measurements of defecation type.
Description
First measurements of both group before intervention using by Bristol Stool Consistency Scale. The Bristol Stool Consistency Scale, developed by a team of gastroenterologists at the University of Bristol, UK; It is used to evaluate stool form and to have information about changes in bowel habits and a pathological formation that may occur in the intestine. This scale was designed to classify an individual's bowel movements in seven distinct categories of stool. According to the Bristol Stool Consistency Scale, Type 1 and Type 2 are constipation, Type 3 and Type 4 are normal stools, and Type 5, Type 6 and Type 7 are diarrhea. It is accepted that there is a direct relationship between stool shape and length of stay in the colon (Lewis and Heaton 1997).
Time Frame
1-7 days
Title
First measurements of gastrointestinal symptoms
Description
First measurements of both groups before the intervention using a Gastrointestinal Symptom Rating Scale.The Turkish validity and reliability of the scale, which was developed by Revicki et al. in 1998 to evaluate the symptoms frequently seen in gastrointestinal system disorders, was performed by Turan and Aştı in 2011. GSRS; It is a 15-item Likert-type scale with options starting from "no discomfort" to "very severe discomfort". Based on factor analysis, 15 items of the GSRS have five sub-dimensions: Abdominal Pain, Reflux, Diarrhea, Indigestion and Constipation. In the GSRS, how the individual felt in terms of gastrointestinal problems in the last week is questioned. High scores on the GSRS indicate that the symptoms are more severe (Revicki et al. 1998; Kaya and Turan 2011; Turan and Aştı 2011).
Time Frame
1-7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Volunteering
Being over 18 years old
No history of gastrointestinal cancer, history of abdominal surgery or abdominal hernia
At least 7 days of clinical treatment
Exclusion Criteria:
Patient information form
Gastrointestinal system rating scale
Constipation assessment scale
Bristol stool consistency scale
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özge Uçar
Organizational Affiliation
Bartin University Health Science Faculty
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nursena Eren
Organizational Affiliation
Bartin University Health Science Faculty
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nisa Ün
Organizational Affiliation
Bartin University Health Science Faculty
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Erdem Altuner
Organizational Affiliation
Bartin University Health Science Faculty
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
İrem Yılmaz
Organizational Affiliation
Bartin University Health Science Faculty
Official's Role
Study Chair
Facility Information:
Facility Name
Özge Uçar
City
Bartın
ZIP/Postal Code
74100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Abdominal Massage on Palliative Care Patients
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