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A clinical trial to compare the efficacy of pain and comfort scores for pain assessment

Completed
Conditions
Pregnancy, childbirth and the puerperium,
Registration Number
CTRI/2017/03/008248
Lead Sponsor
Dayanand Medical College and Hospital
Brief Summary

This is a single blinded randomized study to compare standard pain scores with comfort scores after caesarean section and to determine whether the technique of pain assessment affects patient’s perceptions and experience after caesarean section. One hundred eighty eligible women will be randomly allocated into 2 groups (i.e. group P and group C) of 90 women each, and will be interviewed 6- 24 hours after caesarean section. Group P women will be asked to rate their pain and group C women will be asked to rate their comfort level according to previously validated structured questionnaire. The outcomes of our study is to assess pain severity as measured by a 0–10-point VNRS for pain compared with an equivalent inverted VNRS for comfort and also by a VAS for pain compared with VAS for comfort. Additional outcomes include assessment of level of worry caused by surgical trauma, the requirement of additional analgesia and patient’s perception of postoperative wound as injury or healing

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
180
Inclusion Criteria

All women who underwent caesarean section.

Exclusion Criteria

1.Age less than 18 years 2.Deaf and dumb patients 3.Patients with intellectual disability 4.History of chronic pain or opiate abuse.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Our primary outcome is to assess pain severity as measured by a 0–10-point VNRS for pain compared with an equivalent inverted VNRS for comfort.between 10 to 30 hours
Secondary Outcome Measures
NameTimeMethod
Our secondary outcomes include:1.pain severity as measured by a VAS for pain compared with VAS for comfort;

Trial Locations

Locations (1)

Dayanand Medical College and Hospital

🇮🇳

Ludhiana, PUNJAB, India

Dayanand Medical College and Hospital
🇮🇳Ludhiana, PUNJAB, India
Richa Jain
Principal investigator
9815068242
richajain2105@gmail.com

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