Effect of Guided Imagery and AI-Assisted Video on Pain During Uterine Involution Assessment in Postpartum Women: A Randomized Controlled Trial (GAIUTERUSRCT)

February 25, 2026 updated by: Sehma Aydin Sen, Koç University

The Effect of Guided Imagery and Artificial Intelligence-Assisted Video on Pain During Uterine Involution Assessment in Postpartum Women: A Randomized Controlled Trial

Uterine involution, the process by which the uterus returns to its pre-pregnancy size during the postpartum period, can cause severe cramp-like pain in postpartum women. Although pharmacological methods are common for managing this pain in the literature, their side effects limit their use in this population. This project aims to fill a significant gap in the literature by combining guided imagery, a non-pharmacological technique, with evolving artificial intelligence (AI) technologies. While the effectiveness of guided imagery in cesarean and labor pain is well-known, its impact on pain and physiological parameters during uterine involution-specifically through AI-supported visualization-will be evaluated for the first time within the scope of this study. The primary research question of the project is: "Do guided imagery and AI-supported video applications have a healing effect on the pain levels and vital signs of postpartum women during the evaluation of uterine involution?" This research is a three-arm, randomized controlled experimental study to be conducted at Istanbul Atlas University Hospital. The sample size of the study was determined using the G*Power 3.1 program. As a result of the a priori power analysis performed by selecting the "ANOVA: Fixed effects, omnibus, one-way" statistical test under the "F tests" family, the significance level was set at α = 0.05, the statistical power (1-β) at 0.80, and the effect size (f) at 0.25 (medium effect). The analysis indicated a total sample size of 159 participants for the three groups, with 53 participants required in each group. To account for potential sample attrition, a 10% addition was made to each group, resulting in a planned study with 59 participants per group and a total of 177 participants. "Guided Imagery" and "AI-Supported Video" applications will be utilized as intervention methods. In the guided imagery group, an expert-approved original audio script titled "The Emotional Journey of Mother and Baby" will be played to the women via over-ear headphones during the uterine involution assessment. In the AI-supported video group, a video generated with AI prompts based on the same script will be shown using virtual reality (VR) goggles during the assessment. This will allow for a comparative analysis of the effects of visual and auditory stimuli on pain during the uterine involution evaluation. Participants' pain levels will be measured using the VAS scale, and physiological data (pulse, blood pressure, SpO₂) will be recorded by monitoring at the 60th, 120th, and 180th seconds of the involution process. Considering the moderating effect of anxiety on pain threshold and vital signs, the 'Postpartum Specific Anxiety Scale' will be administered to all participants before the intervention. Data will be analyzed using ANOVA and Kruskal-Wallis tests in the SPSS 23 program.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

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:

  • Age: Postpartum women aged 18 years and older.
  • Obstetric History: Primiparous women who have had a vaginal delivery.
  • Procedure: Presence of an episiotomy during vaginal delivery.
  • Physical Condition: Absence of physical conditions (e.g., postpartum hemorrhage, risk of sepsis) that would interfere with the safe assessment of uterine involution or the implementation of interventions.
  • Technological Competence: Ability to participate in guided imagery and AI-powered video interventions, including the seamless use of digital equipment such as headphones and goggles.
  • Consent: Voluntarily agreeing to participate and signing the informed consent form.

Exclusion Criteria:

  • Medication: Use of analgesic or opioid medications within the last 4-6 hours.
  • Mental Health: History of or current mental health disorders, such as anxiety or depression.
  • Medical Urgency: Requiring intensive care treatment or experiencing medical emergencies during hospitalization.
  • Neonatal Status: Having a newborn admitted to the Neonatal Intensive Care Unit (NICU).
  • Chronic Illness: Diagnosis of any chronic disease.
  • Study Continuity: Inability to continue the study for any reason (e.g., withdrawal due to medical emergencies).
  • Psychological History: Having received or currently receiving psychotherapy or psychological interventions.
  • Communication Barriers: Language barriers or communication difficulties that prevent the accurate application of research tools.
  • Sensory Impairments: Presence of visual or auditory impairments.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Behavioral: Control Group

Definition: Participants in this group will receive standard postpartum care and routine clinical monitoring.

Procedure: Uterine involution assessment will be performed according to the standard hospital protocol without any additional psychological or technological intervention.

Data Collection: Physiological parameters and pain levels will be recorded during and after the routine assessment.
Experimental: Guided Imagery Group
Behavioral: Guided Imagery Group

Definition: This group will receive a guided imagery intervention designed to focus the mind on relaxing images and reduce the perception of pain.

Procedure: Before the uterine involution assessment begins, participants will listen to a structured audio recording (via headphones) that guides them through relaxation techniques and mental imagery.

Implementation: The intervention will continue throughout the assessment process to manage pain and anxiety.
Experimental: AI-Powered Video Group
Behavioral: AI-Powered Video Group

Definition: This group will be exposed to a visual and auditory intervention created using artificial intelligence (AI) tools.

Procedure: Participants will watch a high-fidelity, AI-generated video (e.g., via a tablet or VR goggles) specifically designed to provide cognitive distraction and physiological calming.

Implementation: The video, which synchronizes calming visuals with rhythmic audio, will be played during the uterine involution evaluation to evaluate its impact on pain and vital signs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterus involution pain
Time Frame: first one hour after birth
Pain intensity as measured by the Visual Analog Scale (VAS).
first one hour after birth

Collaborators and Investigators

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

Sponsor

Koç University

Collaborators

Semahat Arsel Nursing Education, Practice and Research Center (SANERC)

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 (Estimated)

February 28, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025.214.IRB2.097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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