Intestinal ObstructionNCT07258017
Impact of Interactive Video Health Intervention on Quality of Life After Bowel Obstruction Surgery
A study testing Conventional care and Interactive Video Health Intervention in people with Intestinal Obstruction and Postoperative Complications, run by Changsha Fourth Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intestinal Obstruction, Postoperative Complications
- What is being tested?
- Conventional care and Interactive Video Health Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2019to 24 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Serious underlying diseases
- Serious mental diseases
- Audio-visual impairment that prevents normal reception of interactive video information
- Poor compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Being tested
- Conventional care, Interactive Video Health Intervention
- Medical subject headings
- Intestinal Obstruction, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional careBehavioural
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.
Interactive Video Health InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Care Control Group | Active comparator | Not described Receives: Behavioral: Conventional care |
| Interactive Video Health Intervention Group | Experimental | Not described Receives: Behavioral: Interactive Video Health Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (QoL) Score
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.
Measured: Baseline (pre-intervention, within 24 hours after surgery) and at hospital discharge (average 8-10 days after randomization).
Secondary outcomes (5)
Time to Relief of Intestinal Obstruction
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.
Measured: From randomization to hospital discharge (daily assessment, average 8-10 days)
Duration of Hospitalization
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.
Measured: From the day of surgery through hospital discharge (an average of 7-10 days)
Electrogastrogram (EGG) Parameters - Gastric Antrum Slow-Wave Amplitude
Gastric antrum slow-wave amplitude measured in microvolts (μV) using electrogastrogram at specified time points.
Measured: 24 hours post-intervention initiati
Electrogastrogram (EGG) Parameters - Gastric Slow-Wave Frequency
Gastric slow-wave frequency measured in cycles per minute (cpm) using electrogastrogram at specified time points.
Measured: 24 hours post-intervention initiation and
Title: Gut Microbiota Diversity (Shannon Index)
Alpha diversity of gut microbiota measured by Shannon index using 16S rRNA sequencing of fecal samples.
Measured: First postoperative defecation (typically 3-5 days post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start10 Jan 2019
- Primary completion13 Jan 2025
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changsha Fourth Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Li Zhang, Changsha Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258017
- Sponsor's protocol ID
- CSSDSYY-YXLL-SC-2024-02-20
- Status last verified
- Jan 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yao L, Wu D, Liu J, Zhang X, Zhang L. 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 trial. Int J Colorectal Dis. 2026 Jan 8;41(1):19. doi: 10.1007/s00384-025-05051-0.
PubMed 41507597
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07258017
- Acronym / sponsor ID
- CSSDSYY-YXLL-SC-2024-02-20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Changsha Fourth HospitalOther government
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Care Control Group | Active comparator | Behavioral: Conventional care |
| Interactive Video Health Intervention Group | Experimental | Behavioral: Interactive Video Health Intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Serious underlying diseases
- Serious mental diseases
- Audio-visual impairment that prevents normal reception of interactive video information
- Poor compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional careStandard 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. | Behavioural | Conventional Care Control Group |
| Interactive Video Health InterventionA 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. | Behavioural | Interactive Video Health Intervention Group |
Primary outcome
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.
5 secondary outcomes
Time to Relief of Intestinal Obstruction
Time frame: 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)
Electrogastrogram (EGG) Parameters - Gastric Antrum Slow-Wave Amplitude
Time frame: 24 hours post-intervention initiati
Electrogastrogram (EGG) Parameters - Gastric Slow-Wave Frequency
Time frame: 24 hours post-intervention initiation and
Title: Gut Microbiota Diversity (Shannon Index)
Time frame: First postoperative defecation (typically 3-5 days post-surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Derived from this study: PubMed 41507597Yao L, Wu D, Liu J, Zhang X, Zhang L. 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 trial. Int J Colorectal Dis. 2026 Jan 8;41(1):19. doi: 10.1007/s00384-025-05051-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional care and Interactive Video Health Intervention in people with Intestinal Obstruction and Postoperative Complications, run by Changsha Fourth Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07258017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.