Postoperative PainVRCSTrailNCT07696949
Virtual Reality and Cryotherapy for Postoperative Pain and Anxiety After Cesarean Section
A study testing Virtual Reality and Cryotherapy in people with Postoperative Pain and Anxiety, run by Shahid Beheshti University of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Pain, Anxiety, Cesarean Section Complications
- What is being tested?
- Virtual Reality and Cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 12 Jul 2026to 12 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effectiveness of Virtual Reality and Cryotherapy on Postoperative Pain and Anxiety Among Women Undergoing Cesarean Section Under Spinal Anesthesia: A Three-Arm Factorial Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Postoperative Pain, Anxiety, Cesarean Section Complications
- Being tested
- Virtual Reality, Cryotherapy
- Keywords
- Virtual Reality, Cryotherapy, Spinal Anesthesia, Postoperative Pain and Anxiety
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called Head-Mounted Display (HMD)
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.
CryotherapyOther
Also called Cold Gel Pack
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Anxiety measured using the Arabic version of the State-Trait Anxiety Inventory (STAI-State).
Measured: 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.
Measured: Up to 6 hours after the intervention.
Total Analgesic Consumption
Total postoperative analgesic consumption during the observation period.
Measured: 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.
Measured: Throughout the intervention and postoperative observation period (up to 6 hours after the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start12 Jul 2026 (estimated)
- Primary completion12 Sep 2026 (estimated)
- Study completion12 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaid Ali Jebur, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696949
- Sponsor's protocol ID
- S.B.M.U.26.858
- Acronym
- VRCSTrail
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
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.
PubMed 34141774Niyonkuru 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.
PubMed 39681763Li 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.
PubMed 21779307
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality and Cryotherapy on Postoperative Pain and Anxiety Among Women Undergoing Cesarean Section Under Spinal Anesthesia: A Three-Arm Factorial Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07696949
- Acronym / sponsor ID
- VRCSTrail / S.B.M.U.26.858
- Conditions
- Postoperative Pain, Anxiety, Cesarean Section Complications
- Keywords
- Virtual Reality, Cryotherapy, Spinal Anesthesia, Postoperative Pain and Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 12 Jul 2026 (estimated)
- Primary completion
- 12 Sep 2026 (estimated)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: 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. |
| Cryotherapy | Experimental | Other: 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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityAlso: Head-Mounted Display (HMD)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. | Device | Virtual Reality |
| CryotherapyAlso: Cold Gel PackParticipants 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. | Other | Cryotherapy |
Primary outcome
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).
Postoperative pain intensity measured using the Visual Analogue Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
4 secondary outcomes
Anxiety Score
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 frame: Up to 6 hours after the intervention.
Total Analgesic Consumption
Time frame: Up to 6 hours after the intervention.
Adverse Events
Time frame: Throughout the intervention and postoperative observation period (up to 6 hours after the intervention).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 34141774Wang 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.
- Background: PubMed 39681763Niyonkuru 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.
- Background: PubMed 21779307Li 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.
- Shahid Beheshti University of Medical SciencesLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Cryotherapy in people with Postoperative Pain and Anxiety, run by Shahid Beheshti University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07696949, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.