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

NCT07445711 | Not Yet Recruiting DMC

• 1 other identifier: 2025.214.IRB2.097
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Uterine Involution; Guided Imagery; Artificial Intelligence (AI); Postpartum Women

Keywords

Artificial Intelligence; Guided Imagery; Pain; Postpartum Women; Uterine Involution

Outcome Measures

Primary Outcomes (1)

• Uterus involution pain

  Pain intensity as measured by the Visual Analog Scale (VAS).

  first one hour after birth

Study Arms (3)

Guided Imagery Group

EXPERIMENTAL

Guided Imagery Group

Behavioral: Guided Imagery Group

AI-Powered Video Group

EXPERIMENTAL

AI-Powered Video Group

Behavioral: AI-Powered Video Group

Control group

OTHER

Control group

Behavioral: Control Group

Interventions

Guided Imagery Group BEHAVIORAL

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.

Guided Imagery Group

AI-Powered Video Group BEHAVIORAL

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.

AI-Powered Video Group

Control Group BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koç University: lead
• Semahat Arsel Nursing Education, Practice and Research Center (SANERC): collaborator

MeSH Terms

Conditions

Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

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: PhD Student

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share