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NCT Number: NCT07445711

Effect of Guided Imagery and AI-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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Uterus involution pain

    Time frame: first one hour after birth

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

Sponsors and collaborators

Lead sponsor

Koç University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: GAIUTERUSRCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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