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Is this the right time to bring change to the Standard Informed consent.

Informed Consent process: Is this the right time to bring change to the Standard Informed consent. A Randomized Control Trial to compare the effect of Standard Informed Consent versus Multimedia Module and Standard Informed Consent on patients understanding of the elective surgical procedures. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070429
Enrollment
500
Registered
2024-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Multimedia COnsent with animation video: Addition of Multimedia Consent with animation video to standard consent during pre op period Control Intervention1: Comparing by knowledge quest

Sponsors

7 Air Force Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patient population above 18 years of age who can give consent and requires a surgical procedure for treatment. Major listed procedures will be Laparoscopic Cholecystectomy, Laparoscopic Appendicectomy, Laparoscopic hernia repair, open hernia repair, Hemorrhoidectomy, Anal Fistulectomy.

Exclusion criteria

Exclusion criteria: Pediatric patient population below 18 years of age Surgery in case of recurrence of disease Emergency surgeries Patients who are unable to give consent

Design outcomes

Primary

MeasureTime frame
To compare whether issuing procedure-specific pictorial handouts and showing informative videos in addition to standard consent forms versus standard consent forms to patients can improve their understanding.Timepoint: preconsent, post consent post op 10 day

Secondary

MeasureTime frame
(i) To assess the pre-op anxiety and post-op risk recall in patients of two different groups. (ii) To evaluate post-op pain perception in patients of two different groups using the Visual Analogue Scale. (iii) To look for factors that influence patient understanding of surgical informed consentTimepoint: preconsent, post consent, postop 10 days

Countries

India

Contacts

Public ContactSV Kulkarni

7 Air Force Hospital

drsvkq@yahoo.com9958645020

Outcome results

None listed

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