NCT04373772

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

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

July 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2016

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

8 months

First QC Date

April 27, 2020

Last Update Submit

April 30, 2020

Conditions

Keywords

Cranial surgerybowel evacuationconstipationabdominal massagenursing

Outcome Measures

Primary Outcomes (2)

  • Primery outcome: bowel sounds

    time return of bowel sounds

    up to 10 days

  • Primery outcome: first defecation

    time of the first defecation

    up to 10 days

Secondary Outcomes (1)

  • constipation risk

    up to 24 hours

Study Arms (2)

abdominal massage group

EXPERIMENTAL

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

Other: abdominal massage

control group

NO INTERVENTION

Routine care for the control group

Interventions

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.

abdominal massage group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details≥18 years old
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: prospective, parallel, two arm (1:1), randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 27, 2020

First Posted

May 4, 2020

Study Start

July 1, 2015

Primary Completion

February 28, 2016

Study Completion

February 28, 2016

Last Updated

May 4, 2020

Record last verified: 2020-04