- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07258017
Impact of Interactive Video Health Intervention on Quality of Life After Bowel Obstruction Surgery
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
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410006
- The Fourth Hospital of Changsha
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSSDSYY-YXLL-SC-2024-02-20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Postoperative Complications
-
Twin Cities Spine CenterAllina Health SystemRecruitingComplications, PostoperativeUnited States
-
Marmara UniversityHacettepe University; Cukurova University; Gazi University; Baskent University; Istanbul... and other collaboratorsNot yet recruitingComplications, PostoperativeTurkey
-
Syed HusainCompletedComplications, PostoperativeUnited States
-
Yale UniversityRecruitingPostoperative Complications (Cardiopulmonary)United States
-
Washington University School of MedicineNational Institute of Nursing Research (NINR)CompletedSurgery | Surgery--Complications | Perioperative/Postoperative ComplicationsUnited States
-
Vastra Gotaland RegionRecruitingSurgery | Lung Infection | Complications, PostoperativeSweden
-
University of PittsburghCompletedLiver Transplant; Complications | Perioperative/Postoperative ComplicationsUnited States
-
Chi Mei Medical HospitalCompletedPostoperative Respiratory Complications | Pain, Postoperative.Taiwan
-
Fujian Medical University Union HospitalNot yet recruitingPostoperative Pulmonary Complications
-
COPAL - My JourneyRecruiting
Clinical Trials on Conventional care
-
First Affiliated Hospital Xi'an Jiaotong UniversityRecruiting
-
The Canadian College of Naturopathic MedicineUnknown
-
Zeng ChanghaoPeking University Sixth Hospital; Mianyang Central HospitalTerminatedNasopharyngeal Carcinoma | DysphagiaChina
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...RecruitingGastrointestinal Stromal Tumors | Nursing CariesChina
-
University of the PhilippinesPfizerCompletedLow Birth Weight Among NeonatesPhilippines
-
Technische Universität DresdenNot yet recruitingIrreversible Loss of Brain Function (ILBF)Germany
-
Peking University Third HospitalRecruitingHyperlipidemia | Cardiometabolic DiseaseChina
-
Applied Physiology Pty LtdTrident Clinical Research Pty LtdCompletedCritical Illness | Intensive CareAustralia
-
Yonsei UniversityRecruitingAdvanced Gastric CancerKorea, Republic of
-
National Cancer Institute, EgyptRecruiting