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Comparing the effect of eyemask with headphones and headset video to decrease anxiety, stress and pain scores in pregnant patients undergoing caesarean section.

A Randomized Control Study comparing the effect of intraoperative external audiovisual blockade, immersive distraction and standard care on anxiety, stress and pain catastrophizing score in parturients undergoing caesarean delivery under spinal anaesthesia - ASPADE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067483
Enrollment
45
Registered
2024-05-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: Immersive Distraction: Distraction using virtual reality video after applying VR headset to the patient intraoperatively, after administration of subarachnoid block and turning the pati

Sponsors

Maulana Azad Medical College and Lok Nayak Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of American Society of Anaesthesiologists (ASA) Physical Status II, III. 2. Singleton pregnancy.

Exclusion criteria

Exclusion criteria: 1. Severe preclampsia, eclampsia. 2. Significant hepatic, renal and cardiovascular disease. 3. Significant vision and hearing impairment. 4. History of generalized anxiety disorder or mental illness 5. Contraindication to spinal anaesthesia. 6. Any psychiatric/ cognitive disorder affecting anxiety and pain assessment. 7. Patients in active labour. 8. Known history of seizures, migraine, motion sickness, claustrophobia.

Design outcomes

Primary

MeasureTime frame
Change in anxiety scores using Novel Visual Facial Anxiety (NVFAS) from baseline to 2 hours post operatively among the three groups.Timepoint: 1. After shifting to OT. 2. Two hours post operatively.—

Secondary

MeasureTime frame
Change in acute pain scores using Numerical Rating Scale (0-10) at different time points.Timepoint: 1. After shifting to OT. 2. At L.A. injection. 3. End of surgery. 4. Two hours post operatively. 5. Six hours post operatively.;Change in anxiety scores using Novel Visual Facial Anxiety (NVFAS) from baseline to the end of surgery and 6 hours post-operatively among the three groups.Timepoint: 1. After shifting to OT. 2. End of surgery. 3. Six hours post operatively.;Change in serum cortisol, serum IL-6, neutrophil lymphocyte ratio and salivary cortisol levels at different time points.Timepoint: Serum cortisol, Serum IL-6 and neutrophil lymphocyte ratio at pre-operatively and 6 hours post operatively. Salivary cortisol at pre-operatively and end of surgery.;Change in stress scores using Brief Measure Of Emotional Perioperative Stress (BMEPS) at different time points.Timepoint: 1. After shifting to OT. 2. End of surgery. 3. Two hours post operatively. 4. Six hours post operatively.;Change in total and subgroup pain catastrophizing score using Pain Catastrophizing Scale (PCS) at different time points.Timepoint: 1. After shifting to OT. 2. End of surgery. 3. Two hours post operatively. 4. Six hours post operatively.;Patient satisfaction questionnaire score and feedback regarding intervention.Timepoint: 2 hours postoperatively.—

Countries

India

Contacts

Public ContactDr Shaivya Srivastava

Maulana Azad Medical College

kapsdr@yahoo.com9871262699

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026