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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04373772
Other study ID # Mersin U
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2015
Est. completion date February 28, 2016

Study information

Verified date April 2020
Source Mersin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date February 28, 2016
Est. primary completion date February 28, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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,

Study Design


Related Conditions & MeSH terms


Intervention

Other:
abdominal massage
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mersin University

Outcome

Type Measure Description Time frame Safety issue
Primary Primery outcome: bowel sounds time return of bowel sounds up to 10 days
Primary Primery outcome: first defecation time of the first defecation up to 10 days
Secondary constipation risk constipation risk in intensive care unit up to 24 hours
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