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Clinical Trials/CTRI/2023/03/050373
CTRI/2023/03/050373Not yet recruitingNot Applicable

Effect Of Preoperative Audio-visual Tools On Quality of Recovery After Elective Caesarean Delivery In A Developing Country Setting - A Randomised Controlled Trial

Post Graduate Institute of Medical Education and Research1 site in 1 country110 target enrollmentStarted: March 20, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
110
Locations
1
Primary Endpoint
Quality of postoperative recovery, as measured using the ObsQoR-10 scoring tool

Study Overview

Brief Summary

Anxiety before elective caesarean delivery is common, and the factors are multifactorial. High preoperative anxiety can have several unfavourable perioperative effects, and is associated with poor patient satisfaction. Preoperative patient preparation using specifically designed audio-visual tools in the local language can help reduce preoperative anxiety. The effect of such interventions on the quality of recovery (QoR) after elective caesarean section has not been studied.

This prospective randomised trial will explore the effect of preoperative audio-visual tools on the postoperative QoR (primary outcome), preoperative anxiety (secondary outcome) and overall patient satisfaction (secondary outcome) in women scheduled to undergo elective caesarean section.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •Parturients planned for elective caesarean section under either neuraxial or general anaesthesia.

Exclusion Criteria

  • •Patient refusal
  • •Parturients who have vision, hearing or speech diabilities
  • •Parturients with psychiatric illnesses
  • •Inability to read and understand the Hindi version of the ObsQoR-10 questionnaire.

Outcomes

Primary Outcomes

Quality of postoperative recovery, as measured using the ObsQoR-10 scoring tool

Time Frame: 24 hours postoperative

Secondary Outcomes

  • Preoperative anxiety, measured using the visual Analogue Scale (VAS)(30 minutes prior to transfer to the operating theatre)
  • Overall patient satisfaction score, measure using a Likert scale(24 hours postoperative)

Investigators

Sponsor
Post Graduate Institute of Medical Education and Research
Sponsor Class
Research institution and hospital

Study Sites (1)

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