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 — DEVICE
    Participants 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 — OTHER
    Participants 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 Reality
    Participants 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: Cryotherapy
    Participants 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 Control
    Participants 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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