Effect of Guided Imagery and AI-Assisted Video on Pain During Uterine Involution Assessment in Postpartum Women: A Randomized Controlled Trial
NCT07445711 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2026-03-03
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
Interventions
- 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.
- 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.
- 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.
Sponsors & Collaborators
-
Semahat Arsel Nursing Education, Practice and Research Center (SANERC)
collaborator UNKNOWN -
Koç University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-28
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
More Related Trials
-
The Effect of the World Health Organisation-Based Intrapartum Care Model on Labour Pain, Comfort, Satisfaction and Postpartum Depression
NCT07451691 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Comparison of Maternal Role Preparation and Awareness-Centred Occupational Therapy Trainings in Pregnant Women
NCT06422780 ·Status: COMPLETED ·Phase: NA
-
The Effect Of Sımulatıon-Based Postpartum Bleedıng Management On Mıdwıfery Students
NCT05928481 ·Status: COMPLETED ·Phase: NA
-
The Effectiveness of the Applications Made in Line With the Algorithm for Coping With Labor Pain
NCT04883047 ·Status: COMPLETED ·Phase: NA
-
The Effect of Pelvic Floor Muscle Exercises Applied During Pregnancy on Genito-Pelvic Pain Level in Postpartum Period
NCT05343520 ·Status: COMPLETED ·Phase: NA
-
Uterine Massage After Vaginal Delivery
NCT03858569 ·Status: COMPLETED ·Phase: NA
-
The Effects of Video-Based and Practical Newborn Bathing Education Provided to Primiparous Pregnant Women During the Third Trimester on Knowledge, Anxiety, and Bonding During the First Bath: a Randomized Controlled Trial
NCT06661408 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Mindfulness-Based Childbirth Education for Pregnant Women With Distress
NCT07122115 ·Status: COMPLETED ·Phase: NA
-
The Effect of Mindfulness Compassionate Living Training on Unwanted Pregnancies
NCT07451418 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Effect of Woman-Centered Care on Anxiety and Comfort Levels
NCT05253664 ·Status: COMPLETED ·Phase: NA
-
The Effect of Mindfulness-Based Sexual Counseling on Body Appreciation, Sexual Distress, and Sexual Self-Confidence in Postpartum Women With Episiotomy
NCT07139704 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Effects of Postpartum Nurse Navigation Program
NCT05225987 ·Status: COMPLETED ·Phase: NA
-
Effects of Awareness-based Parenting and Birth Preparation Education Given to Couples on Materna-paternal Bonding, Birthparameters and Postpartum Harmony
NCT07095088 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
The Effect of Self-made Fetal Movement and Position Tracking During Pregnancy on Maternal Attachment
NCT05443152 ·Status: COMPLETED ·Phase: NA
-
Awareness-Based Parentıng And Bırth Preparatıon Educatıon Gıven To Couples
NCT07100223 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
The Effect of Shower on Birth Pain, Postpartum Fatigue and Comfort
NCT06183957 ·Status: COMPLETED ·Phase: NA
-
The EFFECT of SIMULATION-BASED TRAINING on POSTPARTUM HAEMORRHAGE MANAGEMENT SKILLS
NCT06872879 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Guided Imagery on Pregnancy Stress and Sleep Quality in Risky Pregnancy
NCT06610513 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
The Effect of Psychodrama-Based Group Work
NCT07305571 ·Status: COMPLETED ·Phase: NA
-
The Effect of Guided Imagery Practice on Psychosocial Health and Fear of Childbirth in Primiparous Pregnant Women
NCT06537570 ·Status: COMPLETED ·Phase: NA
-
Nonpharmacological Method and Postpartum Fatigue
NCT05201157 ·Status: COMPLETED ·Phase: NA
-
The Effect of the Menstrual Belt Stress Ball on Pain in Women With Dysmenorrhea
NCT06949397 ·Status: COMPLETED ·Phase: NA
-
The Effect of Self-made Fetal Movement and Position Tracking on Prenatal Attachment and Pregnancy Distress
NCT05313113 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of Telerehabilitation on Pelvic Floor Dysfunction at Postpartum Woman
NCT07228806 ·Status: RECRUITING ·Phase: NA
-
The Effect of Postpartum Debriefing on the Psychological Outcomes
NCT06824480 ·Status: RECRUITING ·Phase: NA