Virtual Reality and Cryotherapy for Postoperative Pain and Anxiety After Cesarean Section
- Sponsor
- Shahid Beheshti University of Medical Sciences
- Study ID
- NCT07696949
- Status
- Not Yet Recruiting
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Conditions
- Anxiety
- Cesarean Section Complications
- Postoperative Pain
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Not accepted
Interventions
- Virtual Reality — DEVICEParticipants receive a 30-minute immersive virtual reality session using a head-mounted display with calming, non-violent audiovisual content during the early postoperative period after cesarean section under spinal anesthesia. The intervention is administered according to a standardized protocol.
- Cryotherapy — OTHERParticipants receive localized cryotherapy using cold gel packs maintained at approximately 10-15°C and applied over or near the cesarean incision area for 15 minutes with a protective barrier between the cold pack and the skin. Skin integrity is monitored before and after treatment.
Study Details
This randomized controlled trial aims to evaluate the effectiveness of virtual reality and cryotherapy, used separately and in combination, in reducing postoperative pain and anxiety among women undergoing cesarean section under spinal anesthesia. Participants will be randomly assigned to one of three intervention groups or a control group according to the study design. Postoperative pain and anxiety will be assessed using validated measurement tools at predetermined time points after surgery. The findings of this study may provide evidence for safe, non-pharmacological interventions to improve postoperative recovery and patient comfort following cesarean section.
Key Dates
- First listed
- Jul 10, 2026
- Start date
- Jul 12, 2026
- Status verified
- Jul 2026
- Primary completion
- Sep 12, 2026
- Completion
- Oct 12, 2026
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Virtual RealityParticipants receive a 30-minute virtual reality intervention using a head-mounted display with calming audiovisual content in addition to routine postoperative care following cesarean section under spinal anesthesia.
- Experimental: CryotherapyParticipants receive cryotherapy using cold gel packs (10-15°C) applied over or near the cesarean incision area for 15 minutes with a protective barrier, in addition to routine postoperative care.
- No Intervention: Routine Care ControlParticipants receive routine postoperative care according to the hospital protocol without virtual reality or cryotherapy during the study assessment period.
Primary Outcome Measure
Postoperative Pain Intensity [ Time Frame: Baseline (pre-intervention), immediately after the intervention, 2 hours after the intervention, and 6 hours after the intervention (if feasible). ]
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