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临床试验/NCT07445711
NCT07445711尚未招募不适用

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

Koç University0 个研究点目标入组 150 人开始时间: 2026年2月28日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
主要终点
Uterus involution pain

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Guided Imagery Group

Experimental

Guided Imagery Group

干预措施: Guided Imagery Group (Behavioral)

AI-Powered Video Group

Experimental

AI-Powered Video Group

干预措施: AI-Powered Video Group (Behavioral)

Control group

Other

Control group

干预措施: Control Group (Behavioral)

结局指标

主要结局

Uterus involution pain

时间窗: first one hour after birth

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

次要结局

未报告次要终点

研究者

发起方
Koç University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sehma Aydin Sen

PhD Student

Koç University

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