NCT06824857

Brief Summary

The study will be conducted as a randomized controlled trial to determine the effect of postoperative abdominal massage on bowel movements in patients who underwent surgery after subarachnoid hemorrhage and are hospitalized in the neurosurgery intensive care unit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

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

September 16, 2024

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

October 11, 2024

Last Update Submit

August 20, 2025

Conditions

Keywords

subarachnoid hemorrhageAbdominal massagebowel movementsnursing

Outcome Measures

Primary Outcomes (3)

  • Time To Defecate

    Time of first defecation

    From the 6th hour after surgery until the end of the 3rd day after surgery

  • Bowel Sounds

    Frequency of bowel sounds heard per minute

    From the 6th hour after surgery until the end of the 3rd day after surgery

  • Abdominal Distension

    To be assessed by measuring the abdominal circumference with a tape measure

    From the 6th hour after surgery until the end of the 3rd day after surgery

Study Arms (2)

Abdominal Massage Application Group

EXPERIMENTAL

After explaining the purpose of the study to the relatives of patients in the abdominal massage group, the "Introductory Characteristics Form" will be filled out. Abdominal massage will be performed according to the Checklist at the 6th hour after surgery and at the same times in the morning and evening for the first 3 days post-surgery. Before and 15 minutes after the abdominal massage application, bowel sounds will be auscultated, abdominal circumference will be measured with a measuring tape, and abdominal tension will be observed and recorded in the patient follow-up form.

Other: Abdominal Massage Application

Control Group

NO INTERVENTION

After explaining the purpose of the study to the relatives of patients in the control group, the "Introductory Characteristics Form" will be filled out. At the same times as the experimental group, bowel sounds will be auscultated in the control group without any intervention, abdominal circumference will be measured with a measuring tape, and abdominal tension will be observed

Interventions

As part of the abdominal massage application, patient follow-up forms and checklists were prepared. Before starting the study, the abdominal massage practitioner participated in a certification program on this topic and received a competency certificate. Patients will be followed up for the first 3 days postoperatively using the prepared patient follow-up forms. Abdominal massage will be applied to each patient for 15 minutes according to a certain standard as stated in the literature

Abdominal Massage Application Group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 18 years of age or older
  • Underwent neurovascular surgery
  • Received general anesthesia
  • Have no wounds, surgical intervention, or radiotherapy in the abdominal region
  • Have no bowel obstruction, irritable bowel syndrome, inflammatory bowel disease, abdominal herniation, or bowel cancer
  • Began oral feeding at the 6th hour post-surgery
  • Stayed in the intensive care unit for 3 or more days
  • Have a Glasgow Coma Scale (GCS) score of 9 or above
  • Have no signs of acute abdomen
  • Have no intra-abdominal infection
  • No mechanical ventilation
  • Mobilezed in the preoperative period
  • Unable to mobilize after surgery
  • Evaluated by the intensive care physician with no contraindications for abdominal massage
  • Have a first-degree relative who has given consent

You may not qualify if:

  • Patients with the following conditions will be excluded from the sample:
  • Those with chronic constipation, fecal incontinence, or diarrhea
  • Those fed with a fiber-enriched nutritional solution (e.g., Nutrison Protein Plus Multifibre®, Fresubin Original Fibre®, Isosource Fiber®, Jevity Plus®)
  • Those fed via nasogastric enteral tube
  • Those receiving parenteral nutrition
  • Patients with a BMI \> 40 (morbid obesity)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Nursing, Gazi University

Ankara, 06490, Turkey (Türkiye)

Location

Gazi University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, PhD, Assistant Professor

Study Record Dates

First Submitted

October 11, 2024

First Posted

February 13, 2025

Study Start

September 16, 2024

Primary Completion

March 20, 2025

Study Completion

March 20, 2025

Last Updated

August 21, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations