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Effect of Abdominal Massage on Bowel Evacuation After Cranial Surgery

Primary Purpose

Constipation, Abdominal Massage

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

abdominal massage

About this trial

This is an interventional supportive care trial for Constipation focused on measuring Cranial surgery, bowel evacuation, constipation, abdominal massage, nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who

volunteered to participate in the study,
were 18 years old or older and underwent CS,
stayed in the ICU for ≥ 3 days,

Exclusion Criteria: Patients who

have percutaneous endoscopic gastrostomy,
abdominal hernia,
irritable bowel syndrome
bowel cancer,
history of abdominal surgery,
pregnancy,

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

abdominal massage group

control group

Arm Description

the abdominal massage group received a total of 30 minutes of massage, 15 minutes every morning and evening, until the first defecation.

Routine care for the control group

Outcomes

Primary Outcome Measures

Primery outcome: bowel sounds

time return of bowel sounds

Primery outcome: first defecation

time of the first defecation

Secondary Outcome Measures

constipation risk

constipation risk in intensive care unit

Full Information

NCT ID

NCT04373772

First Posted

April 27, 2020

Last Updated

April 30, 2020

Sponsor

Mersin University

1. Study Identification

Unique Protocol Identification Number

NCT04373772

Brief Title

Effect of Abdominal Massage on Bowel Evacuation After Cranial Surgery

Official Title

The Effect of Abdominal Massage on Bowel Evacuation After Cranial Surgery: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

July 1, 2015 (Actual)

Primary Completion Date

February 28, 2016 (Actual)

Study Completion Date

February 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mersin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Many factors in patients undergoing cranial surgery (CS) may affect the bowel evacuation of patients, resulting in constipation, which could lead to the use of the valsalva maneuver. The aim of this study was to determine the effect of abdominal massage (AM) on bowel evacuation of patients treated in intensive care units (ICU) after CS.

Detailed Description

The sample of this prospective parallel two-arm randomized controlled trial included 80 patients who underwent CS. The patients were randomly assigned (1:1) to the AM and control groups. The constipation risk of all the patients following CS was assessed with Constipation Risk Assessment Scale (CRAS). Those patients in the AM group received a total of 30 minutes of massage, 15 minutes every morning and evening, until the first defecation. The bowel sounds of all the patients in the AM and control groups were assessed on a daily basis. The days when bowel sounds were heard and the first defecation took place were recorded in a Bowel Evacuation Form.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation, Abdominal Massage

Keywords

Cranial surgery, bowel evacuation, constipation, abdominal massage, nursing

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

prospective, parallel, two arm (1:1), randomized controlled clinical trial

Masking

Participant

Masking Description

In this study, due to the nature of the intervention, only the patient was blinded. The researchers involved in the running of the study were not blinded.

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

abdominal massage group

Arm Type

Experimental

Arm Description

the abdominal massage group received a total of 30 minutes of massage, 15 minutes every morning and evening, until the first defecation.

Arm Title

control group

Arm Type

No Intervention

Arm Description

Routine care for the control group

Intervention Type

Other

Intervention Name(s)

abdominal massage

Intervention Description

the patients in the AM group were given a total of 30 minutes of AM by the nurses (HD, OM) everyday for 15 minutes in the morning and evening.In this study AM, which included effleurage, strokes, petrissage and vibration techniques, was applied to the patients for 15 minutes in each session at 9:00 am and 9:00 pm.

Primary Outcome Measure Information:

Title

Primery outcome: bowel sounds

Description

time return of bowel sounds

Time Frame

up to 10 days

Title

Primery outcome: first defecation

Description

time of the first defecation

Time Frame

up to 10 days

Secondary Outcome Measure Information:

Title

constipation risk

Description

constipation risk in intensive care unit

Time Frame

up to 24 hours

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

≥18 years old

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who volunteered to participate in the study, were 18 years old or older and underwent CS, stayed in the ICU for ≥ 3 days, Exclusion Criteria: Patients who have percutaneous endoscopic gastrostomy, abdominal hernia, irritable bowel syndrome bowel cancer, history of abdominal surgery, pregnancy,

12. IPD Sharing Statement

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Effect of Abdominal Massage on Bowel Evacuation After Cranial Surgery

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