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Virtual Reality and Cryotherapy for Postoperative Pain and Anxiety After Cesarean Section

ConditionsPostoperative PainAnxietyCesarean Section Complications
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorShahid Beheshti University of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Virtual RealityExperimental treatment 1 intervention
Group B: CryotherapyExperimental treatment 1 intervention
Group C: Routine Care ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Postoperative Pain Intensity

Postoperative pain intensity measured using the Visual Analogue Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).

Time frame
Baseline (pre-intervention), immediately after the intervention, 2 hours after the intervention, and 6 hours after the intervention (if feasible).

Secondary outcomes

1

Anxiety Score

Anxiety measured using the Arabic version of the State-Trait Anxiety Inventory (STAI-State).

Time frame
Baseline (pre-intervention), immediately after the intervention, 2 hours after the intervention, and 6 hours after the intervention (if feasible).
2

Time to First Rescue Analgesia

Time from completion of the intervention to the first administration of rescue analgesic medication.

Time frame
Up to 6 hours after the intervention.
3

Total Analgesic Consumption

Total postoperative analgesic consumption during the observation period.

Time frame
Up to 6 hours after the intervention.
4

Adverse Events

Incidence of adverse events related to virtual reality or cryotherapy, including dizziness, nausea, headache, eye strain, motion sickness, excessive cold sensation, skin redness, numbness, burning sensation, or other treatment-related events.

Time frame
Throughout the intervention and postoperative observation period (up to 6 hours after the intervention).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shahid Beheshti University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: