Anxiety, Cesarean Section Complications, Postoperative Pain
Conditions
Keywords
Virtual Reality, Cryotherapy, Spinal Anesthesia, Postoperative Pain and Anxiety
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.
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.
Interventions
DEVICEVirtual Reality
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.
OTHERCryotherapy
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.
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
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.
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 hypersensitivity, Raynaud's phenomenon, or allergy/intolerance to cryotherapy. Severe intraoperative or postoperative bleeding. Refusal to participate or withdrawal of informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Score | Baseline (pre-intervention), immediately after the intervention, 2 hours after the intervention, and 6 hours after the intervention (if feasible). | Anxiety measured using the Arabic version of the State-Trait Anxiety Inventory (STAI-State). |
| Time to First Rescue Analgesia | Up to 6 hours after the intervention. | Time from completion of the intervention to the first administration of rescue analgesic medication. |
| Total Analgesic Consumption | Up to 6 hours after the intervention. | Total postoperative analgesic consumption during the observation period. |
| Adverse Events | Throughout the intervention and postoperative observation period (up to 6 hours after the intervention). | 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. |
Outcome results
None listed