ClinicalTrials.gg
CompletedNCT04757402Updated Oct 31, 2023

Role of Preoperative Counselling With NSQIP Surgical Risk Calculator

An interventional study of Counselling with NSQIP Surgical risk calculator in Satisfaction, Patient, sponsored by Nepal Mediciti Hospital. Completed at 1 site in Nepal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by Nepal Mediciti Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Surgical patients undergo preoperative counseling which varies in quality and duration. Proper communication during the preoperative consultation can deliver relevant health information and guide improvement of perioperative health status. The methods, however, are non-standardized and the explanation of the postoperative course is generally vague or varies from person to person. We hypothesize that high-risk patients who receive pre-operative counseling with the help of the NSQIP surgical risk calculator compared to the current standard of care will have higher satisfaction concerning information on the perioperative journey.

Read the detailed description

The control arm will receive standard preoperative counselling and written consent will be taken.

The NSQIP arm will receive standard preoperative counselling along with the details provided by NSQIP Surgical risk calculator and written consent will be taken.

Anxiety among the patients will be accessed with the use of Preoperative anxiety measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire written in Nepali.

Duration of counselling period will be noted from the start of counselling session till the consent is signed.

02

Conditions studied

  • Satisfaction, Patient

Keywords

  • NSQIP Surgical risk calculator
  • Preoperative counselling
  • Anxiety
03

In context

Patient Satisfaction

877 studies on the registry are indexed under Patient Satisfaction; 202 are open to participants now.

This study's enrollment of 66 is below the median of 96 across 624 interventional studies indexed under Patient Satisfaction.

Browse Patient Satisfaction studies →

Lead sponsor

Nepal Mediciti Hospital is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • or above and/or age above 65 high-risk surgical patients undergoing surgery at Nepal Mediciti Hospital

Exclusion criteria

Exclusion Criteria:

  • Adults who cannot consent Pregnant women Non-Nepali speakers Consent by surrogate
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • Active comparator
    Control arm

    All eligible candidates will be receiving standard preoperative counselling as per the hospital standards and protocols. The patient will fill five-points Amsterdam Preoperative Anxiety and Information Scale (APAIS) form for anxiety evaluation and Seven-points Likert Scale form for satisfaction regarding the counselling.

    Other: Counselling with NSQIP Surgical risk calculator

  • Experimental
    NSQIP Arm

    All eligible candidates will be receiving standard preoperative counselling as per the control arm PLUS the risk will be explained using the scores from the NSQIP surgical risk calculator. The anxiety and the satisfaction scores will be recorded as in the control arm.

    Other: Counselling with NSQIP Surgical risk calculator

Interventions

  • OtherCounselling with NSQIP Surgical risk calculator

    Use of NSQIP surgical risk calculator to check for patient satisfaction regarding pre operative counseling.

06

What researchers measure

Primary outcomes

  1. The difference in patient satisfaction as assessed by a 7-point Likert scale

    The study will compare patient satisfaction scores between the two arms of the study groups to determine if there is a difference in patient satisfaction. It will be based on a scale of 1 to 7, 7 being the most satisfied and 1 being the least.

    Time frame: 5 MONTHS

Secondary outcomes

  1. Preoperative anxiety measured by Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire written in Nepalese

    Anxiety evaluation during preoperative counselling will be done by APAIS using a five point scale,5 being the most anxious and 1 being the least.

    Time frame: 5 months

  2. Duration of counseling

    time taken to complete preoperative counseling which will be noted from start of counseling to the time when consent is signed.

    Time frame: 5 months

07

Study locations

1 site
  • Bikash Khadka
    Kathmandu, Bagmati 44600, Nepal
08

References and documents

Publications

  • Sigdel S, Ozaki A, Basnet M, Kobashi Y, Pradhan B, Higuchi A, Uprety A. Anxiety evaluation in Nepalese adult patients awaiting cardiac surgery: A prospective observational study. Medicine (Baltimore). 2020 Feb;99(9):e19302. doi: 10.1097/MD.0000000000019302. PubMed 32118748 ↗

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Study protocol

Time frame: 10 months

Access criteria: an email with explanations for the need of data

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04757402
Lead sponsor
Nepal Mediciti Hospital
Responsible party
Bikash Khadka (Anesthesiologist, Nepal Mediciti Hospital) — Principal investigator
First posted
Feb 17, 2021
Start date
Apr 1, 2021
Primary completion
Sep 20, 2023
Completion
Oct 28, 2023
Last update
Oct 31, 2023

Study contacts

Apurb Sharma, MD
study chair · Nepal Mediciti Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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