NCT05580679

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

October 7, 2022

Last Update Submit

September 17, 2023

Conditions

Keywords

palliativepalliative carenursingabdominal massageconstipation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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).

    1-7 days

Study Arms (2)

Abdominal massage group

EXPERIMENTAL

Abdominal massage using for evaluation of constipation.

Other: Abdominal massage

Standart care group

NO INTERVENTION

No intervention palliative care patient

Interventions

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

Abdominal massage group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Patient information form
  • Gastrointestinal system rating scale
  • Constipation assessment scale
  • Bristol stool consistency scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özge Uçar

Bartın, 74100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ConstipationAbdominal Pain

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic Manifestations

Study Officials

  • Özge Uçar

    Bartin University Health Science Faculty

    PRINCIPAL INVESTIGATOR
  • Nursena Eren

    Bartin University Health Science Faculty

    STUDY DIRECTOR
  • Nisa Ün

    Bartin University Health Science Faculty

    STUDY CHAIR
  • Erdem Altuner

    Bartin University Health Science Faculty

    STUDY CHAIR
  • İrem Yılmaz

    Bartin University Health Science Faculty

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Randomized Controlled Trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 7, 2022

First Posted

October 14, 2022

Study Start

March 15, 2022

Primary Completion

August 30, 2022

Study Completion

December 30, 2022

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations