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

NCT07696949 | Not Yet Recruiting

• 1 other identifier: S.B.M.U.26.858
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Pain; Anxiety; Cesarean Section Complications

Keywords

Virtual Reality; Cryotherapy; Spinal Anesthesia; Postoperative Pain and Anxiety

Outcome Measures

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).

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

Secondary Outcomes (4)

• Anxiety Score

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

• Time to First Rescue Analgesia

  Up to 6 hours after the intervention.

• Total Analgesic Consumption

  Up to 6 hours after the intervention.

• Adverse Events

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

Study Arms (3)

Virtual Reality

EXPERIMENTAL

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.

Device: Virtual Reality

Cryotherapy

EXPERIMENTAL

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.

Other: Cryotherapy

Routine Care Control

NO INTERVENTION

Participants receive routine postoperative care according to the hospital protocol without virtual reality or cryotherapy during the study assessment period.

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.

Also known as: Head-Mounted Display (HMD)

Virtual Reality

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.

Also known as: Cold Gel Pack

Cryotherapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants aged 18 to 45 years. Undergoing elective or emergency cesarean section under spinal anesthesia. Hemodynamically stable after surgery. Able to understand Arabic. Conscious, oriented, and able to complete study questionnaires. Willing to participate and provide written informed consent.

You may not qualify if:

• Undergoing cesarean section under general anesthesia. Severe postoperative complications requiring intensive care. Severe visual or hearing impairment preventing virtual reality use. History of epilepsy or seizure disorder. Severe motion sickness or vestibular disorders. Known psychiatric illness interfering with outcome assessment. Cognitive impairment preventing completion of questionnaires. Skin disease, wound complications, cold hypersensitivity, Raynaud's phenomenon, or allergy/intolerance to cryotherapy.
• Severe intraoperative or postoperative bleeding. Refusal to participate or withdrawal of informed consent.

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Related Publications (3)

• Wang ZR, Ni GX. Is it time to put traditional cold therapy in rehabilitation of soft-tissue injuries out to pasture? World J Clin Cases. 2021 Jun 16;9(17):4116-4122. doi: 10.12998/wjcc.v9.i17.4116.

  PMID: 34141774 BACKGROUND

• Niyonkuru E, Iqbal MA, Zhang X, Ma P. Complementary Approaches to Postoperative Pain Management: A Review of Non-pharmacological Interventions. Pain Ther. 2025 Feb;14(1):121-144. doi: 10.1007/s40122-024-00688-1. Epub 2024 Dec 17.

  PMID: 39681763 BACKGROUND

• Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.

  PMID: 21779307 BACKGROUND

Related Links

• Shahid Beheshti University of Medical Sciences

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders

Interventions

Smart Glasses; Cryotherapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, participants and care providers cannot be blinded. Outcome assessors will be blinded to group allocation whenever feasible. Data analysis will be performed using coded treatment groups until completion of the primary analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student

Model Details: Participants will be randomly assigned to one of three parallel groups: Virtual Reality plus routine care, Cryotherapy plus routine care, or Routine Care alone. Number of Arms 3

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 12, 2026
• Primary Completion (Estimated): September 12, 2026
• Study Completion (Estimated): October 12, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share