Uterine InvolutionGAIUTERUSRCTNCT07445711
Effect of Guided Imagery and AI-Assisted Video on Pain During Uterine Involution Assessment in Postpartum Women: A Randomized Controlled Trial
A study testing Guided Imagery Group and AI-Powered Video Group in people with Uterine Involution and Guided Imagery, run by Koç University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Involution, Guided Imagery, Artificial Intelligence (AI)
- What is being tested?
- Guided Imagery Group and AI-Powered Video Group
- 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
- 150 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
About this study
Official title: 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.
- Being tested
- Guided Imagery Group, AI-Powered Video Group, Control Group
- Keywords
- Artificial Intelligence, Guided Imagery, Pain, Postpartum Women, Uterine Involution
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Imagery GroupBehavioural
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 GroupBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided Imagery Group | Experimental | Guided Imagery Group Receives: Behavioral: Guided Imagery Group |
| AI-Powered Video Group | Experimental | AI-Powered Video Group Receives: Behavioral: AI-Powered Video Group |
| Control group | Other | Control group Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterus involution pain
Pain intensity as measured by the Visual Analog Scale (VAS).
Measured: first one hour after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start28 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine InvolutionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Semahat Arsel Nursing Education, Practice and Research Center (SANERC)
- Responsible party
- Principal investigator, Sehma Aydin Sen, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445711
- Sponsor's protocol ID
- 2025.214.IRB2.097
- Acronym
- GAIUTERUSRCT
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Guided Imagery and Artificial Intelligence-Assisted Video on Pain During Uterine Involution Assessment in Postpartum Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07445711
- Acronym / sponsor ID
- GAIUTERUSRCT / 2025.214.IRB2.097
- Keywords
- Artificial Intelligence, Guided Imagery, Pain, Postpartum Women, Uterine Involution
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Semahat Arsel Nursing Education, Practice and Research Center (SANERC)
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2026 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery Group | Experimental | Behavioral: Guided Imagery GroupGuided Imagery Group |
| AI-Powered Video Group | Experimental | Behavioral: AI-Powered Video GroupAI-Powered Video Group |
| Control group | Other | Behavioral: Control GroupControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Guided Imagery GroupDefinition: 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. | Behavioural | Guided Imagery Group |
| AI-Powered Video GroupDefinition: 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. | Behavioural | AI-Powered Video Group |
| Control GroupDefinition: 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. | Behavioural | Control group |
Primary outcome
Uterus involution pain
Time frame: first one hour after birth
Pain intensity as measured by the Visual Analog Scale (VAS).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Uterine Involution
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery Group and AI-Powered Video Group in people with Uterine Involution and Guided Imagery, run by Koç University.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Uterus involution pain (time frame: first one hour after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2026.