Impact of Interactive Video Health Intervention on Quality of Life After Bowel Obstruction Surgery

November 20, 2025 updated by: Li Zhang, Changsha Fourth Hospital

Multidimensional Impact Analysis of Interactive Video Health Intervention on Quality of Life and Clinical Rehabilitation Indicators in Patients With Early Postoperative Bowel Obstruction: A Randomized Controlled Tria

Objective: To investigate the multidimensional effects of an interactive video health intervention on the quality of life and clinical rehabilitation indicators of patients with early postoperative bowel obstruction.

Methods: The study consists of two phases. Phase 1 (January 2019-December 2020) involves the development and psychometric validation of a Postoperative Quality of Life Assessment Scale for Early Intestinal Obstruction, with approximately 150 patients. Phase 2 (January 2021-January 2025) is a randomized controlled trial enrolling about 310 eligible patients (aged 18-75 years, with basic cognitive ability, diagnosed with early postoperative bowel obstruction after abdominal surgery). Participants are randomly assigned to either a control group (conventional care, including condition monitoring, basic treatment, and non-structured health education) or a study group (conventional care plus an interactive video health intervention consisting of five modular videos covering disease knowledge, rehabilitation, and diet, initiated 24 hours post-surgery).

Primary and secondary outcomes will include quality of life (assessed with the validated scale), clinical rehabilitation indicators (such as obstruction relief time and hospitalization duration), electrogastrogram parameters, and gut microbiota diversity (16S rRNA sequencing).

Study Overview

Study Type

Interventional

Enrollment (Actual)

462

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hunan
      • Changsha, Hunan, China, 410006
        • The Fourth Hospital of Changsha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with early postoperative intestinal obstruction after abdominal surgery based on clinical symptoms, physical examination and imaging
  • Aged between 18 and 75 years
  • With basic cognitive ability and comprehension
  • Informed consent obtained directly from patients; family members provided supplementary consent

Exclusion Criteria:

  • Serious underlying diseases
  • Serious mental diseases
  • Audio-visual impairment that prevents normal reception of interactive video information
  • Poor compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Care Control Group
Standard conventional care including condition monitoring, basic medical treatment (gastrointestinal decompression, fluid replacement, correction of water-electrolyte disorders), and non-structured health education. Represents the current standard of care for postoperative bowel obstruction patients without the additional video-based intervention component.
Experimental: Interactive Video Health Intervention Group
A structured interactive video intervention consisting of 5 modular videos covering disease knowledge, rehabilitation exercises, and dietary guidance. The videos use animation demonstrations, case analyses, and expert explanations, with interactive elements such as Q&A sessions and polls. Initiated 24 hours post-surgery, patients can self-paced viewing using tablet devices with researcher support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QoL) Score
Time Frame: Baseline (pre-intervention, within 24 hours after surgery) and at hospital discharge (average 8-10 days after randomization).
Scale consists of multiple domains assessing physical, psychological, and social functioning. Scores range from 0 to 100, with higher scores indicating better quality of life.
Baseline (pre-intervention, within 24 hours after surgery) and at hospital discharge (average 8-10 days after randomization).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Relief of Intestinal Obstruction
Time Frame: From randomization to hospital discharge (daily assessment, average 8-10 days)
Time from randomization to relief of intestinal obstruction symptoms (abdominal pain, distension, and resumption of defecation/flatus), measured in hours using daily clinical evaluation and patient report.
From randomization to hospital discharge (daily assessment, average 8-10 days)
Duration of Hospitalization
Time Frame: From the day of surgery through hospital discharge (an average of 7-10 days)
Total number of days from the date of surgery to the date of hospital discharge, as recorded in hospital medical records. This indicator reflects postoperative recovery efficiency and the impact of the interactive video intervention on clinical outcomes.
From the day of surgery through hospital discharge (an average of 7-10 days)
Electrogastrogram (EGG) Parameters - Gastric Antrum Slow-Wave Amplitude
Time Frame: 24 hours post-intervention initiati
Gastric antrum slow-wave amplitude measured in microvolts (μV) using electrogastrogram at specified time points.
24 hours post-intervention initiati
Electrogastrogram (EGG) Parameters - Gastric Slow-Wave Frequency
Time Frame: 24 hours post-intervention initiation and
Gastric slow-wave frequency measured in cycles per minute (cpm) using electrogastrogram at specified time points.
24 hours post-intervention initiation and
Title: Gut Microbiota Diversity (Shannon Index)
Time Frame: First postoperative defecation (typically 3-5 days post-surgery)
Alpha diversity of gut microbiota measured by Shannon index using 16S rRNA sequencing of fecal samples.
First postoperative defecation (typically 3-5 days post-surgery)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Quality of Life Assessment Scale Validation - Reliability Metrics
Time Frame: At postoperative day 7 (single assessment after intervention)
Internal consistency of the Postoperative Quality of Life Assessment Scale for Early Intestinal Obstruction, assessed using Cronbach's alpha (range 0-1; higher scores indicate better internal consistency).
At postoperative day 7 (single assessment after intervention)
Postoperative Quality of Life Assessment Scale Validation - Construct Validity Metrics
Time Frame: At postoperative day 7 (single assessment after intervention)
Construct validity of the Postoperative Quality of Life Assessment Scale for Early Intestinal Obstruction (PQOL-EO), assessed using Average Variance Extracted (AVE) and Composite Reliability (CR). Both are unitless indices (range 0-1), where higher values indicate better construct validity and internal consistency of the scale.
At postoperative day 7 (single assessment after intervention)
Expert Consensus Agreement on Questionnaire Items
Time Frame: During the pre-intervention development phase (single assessment prior to participant enrollment)
Percentage of questionnaire items rated as "appropriate" or "highly relevant" by an expert panel using a 5-point Likert scale (1 = not relevant to 5 = highly relevant). Higher scores indicate greater content validity and expert consensus regarding the Postoperative Quality of Life Assessment Scale for Early Intestinal Obstruction (PQOL-EO).
During the pre-intervention development phase (single assessment prior to participant enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

January 13, 2025

Study Completion (Actual)

January 24, 2025

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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