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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05580679
Other study ID # 1919B012101971
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2022
Est. completion date December 30, 2022

Study information

Verified date September 2023
Source Bartin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date December 30, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Abdominal massage
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

Locations

Country Name City State
Turkey Özge Uçar Bartin

Sponsors (2)

Lead Sponsor Collaborator
Bartin University The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 1-7 days
Primary 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 Asti 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 Asti 2011). 1-7 days
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