NCT05742672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

December 19, 2022

Last Update Submit

September 11, 2023

Conditions

Keywords

Abdominal massagePalliative careConstipationQuality of Life

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 weeks

Study Arms (1)

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.

Other: ABDOMINAL MASSAGE APPLICATION

Interventions

* 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.

Massage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A first-degree relative or volunteer to participate in the research approved to participate in the research by
  • years and over,
  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sevil PAMUK CEBECİ

Eskişehir, Eskişehir, 26020, Turkey (Türkiye)

Location

Eskişehir Şehir Hastanesi

Eskişehir, 26020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sevil PAMUK CEBECİ, Asst.Prof.

    sevil.pamukcebeci@ogu.edu.tr

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.Dr.

Study Record Dates

First Submitted

December 19, 2022

First Posted

February 24, 2023

Study Start

December 1, 2022

Primary Completion

May 30, 2023

Study Completion

June 30, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations