An interventional study of Virtual Reality and Cryotherapy in Postoperative Pain, Anxiety and Cesarean Section Complications, sponsored by Shahid Beheshti University of Medical Sciences. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Shahid Beheshti University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
Cesarean section is one of the most commonly performed surgical procedures worldwide. Despite advances in perioperative care, many women continue to experience moderate to severe postoperative pain and anxiety, which can negatively affect early mobilization, breastfeeding, maternal-infant bonding, and overall recovery. Although pharmacological analgesia remains the standard of care, non-pharmacological interventions may provide additional benefits while minimizing medication-related adverse effects.
Virtual reality is an immersive distraction technique that has shown promise in reducing pain perception and anxiety in various clinical settings. Cryotherapy is another non-pharmacological intervention that may reduce pain through local cooling, decreased nerve conduction velocity, and reduced inflammatory responses. However, evidence regarding their combined effectiveness after cesarean section remains limited.
The purpose of this randomized controlled trial is to evaluate the effectiveness of virtual reality and cryotherapy, individually and in combination, on postoperative pain and anxiety among women undergoing cesarean section under spinal anesthesia. Eligible participants will be randomly allocated to the study groups according to the trial protocol. Pain and anxiety outcomes will be measured using validated assessment instruments at predefined postoperative time points. The primary outcomes are postoperative pain intensity and anxiety. The results are expected to contribute to evidence-based postoperative nursing care by identifying effective, safe, and feasible non-pharmacological interventions for women undergoing cesarean section.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 120 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Shahid Beheshti University of Medical Sciences is the lead sponsor of 229 studies on the registry; 19 are open to participants now.
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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 .
Exclusion Criteria:
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 , Raynaud's phenomenon, or allergy/intolerance to cryotherapy.
Severe intraoperative or postoperative bleeding. Refusal to participate or withdrawal of .
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Participants receive routine postoperative care according to the hospital protocol without virtual reality or cryotherapy during the study assessment period.
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)
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
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).
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).
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.
Total Analgesic Consumption
Total postoperative analgesic consumption during the observation period.
Time frame: Up to 6 hours after the intervention.
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).
No study locations are listed for this record.
Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers.
Start is estimated for Jul 2026; primary completion for Sep 2026, 2 months later.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 2 months is below that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Shahid Beheshti University of Medical Sciences →