Does Showing Video Information About Spinal Anesthesia Relieves Patient Anxiety?

January 7, 2021 updated by: Dr Deepak Bhandari, Chitwan Medical College

Effect of Multimedia Video Information in Relieving Anxiety Related to Spinalanesthesia. A Randomized Control Trial

Our primary aim is to compare the effect of pre-operative multimedia video information on perioperative anxiety and hemodynamic parameters.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Anxiety is common in perioperative patients with incidence of 60-89 %. Lack of knowledge about surgery and anesthesia, anesthesia procedures and unfamiliar surroundings are the common causes of anxiety . Anxiety related to anesthesia can be due to lack of knowledge about its process, procedures and risk associated with it or misconceptions about it. Long NPO status and unexpected delay before and during anesthesia procedure and surgery further increases the anxiety in perioperative patients. Anxiety increases the activity of sympathetic nervous system and cause preoperative and intraoperative tachycardia, hypertension, arrhythmias, increased pain perception and increase requirement of anaesthetic drugs. This may lead to harmful effect on patient health and decrease overall patient satisfaction and even traumatic experience for rest of life. This may affect process of giving informed consent for the planned surgery. Many measures are taken to allay anxiety in perioperative patients. Anxiolytic medications are given preoperative period to allay anxiety but they may have detrimental effect on patient health, requires administration under supervision of health professional and may not be effective unless the cause of anxiety is taken care. Counselling regarding the procedure of anesthesia during pre-anesthetic check up is other way to allay anxiety but transfer of knowledge is usually limited and may not be entirely retained. Other method in the form of written pamphlets, booklet or questionnaires have been tried but most of the patients in Nepal are not literate enough to read and understand it. Multimedia information to allay patient's anxiety has been successfully tried. Previous study shows a significant reduction in anxiety level due to preoperative multimedia information among the patients undergoing surgery. Investigators have developed a short visual clip of 4.5 minutes duration depicting the procedure of spinal anaesthesia .Investigators will be using Hamilton Anxiety Score in patients undergoing surgical procedures under spinal anesthesia .

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- All patients between 18 and 65 years of age of either sex undergoing elective surgery under SAB were included.Only patients in ASA category 1 and 2 will be included.

Exclusion Criteria:

  • Patients refusing to give consent for the study,

    • Patients Having significant cardiovascular or neurological disease,
    • Patients On medications such as beta blockers, antidepressants, cardiac or psychiatric drugs,
    • Pregnant patients and
    • Patients those who had undergone procedures under SAB in the past
    • Patients facing any major complications after the surgery such as massive blood loss, having to convert to general anesthesia due to lengthy surgical procedure, patients requiring critical care administration after the surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video Group

Video Group

multimedia video information of 4.5 mins regarding procedure, indication and complications related to spinal anesthesia will be shown to patients in intervention group , patient will be allowed to ask questions.
Behavioral: Multimedia video information

During pre anesthesia visit after regular pre anesthesia check up patient will be asked to fill the Hamilton scoring questionnaire about anxiety.

After this a multimedia video information about spinal anesthesia of around 6 minutes will be shown to the intervention group during pre anesthesia visit. This video will contain explanation about how spinal anesthesia procedure is conducted. Patient will be allowed to ask questions.

On the day of surgery in the pre surgical area again Hamilton scoring questionnaire will be asked with the patients to check the level of anxiety.
No Intervention: non video group
patients in control group will be given verbal information regarding procedure, indication and complication, patient will be allowed to ask questions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anxiety
Time Frame: 1) During pre anesthesia check up before providing verbal or multimedia information. 2) one hour before the surgery 3) 8 hours after the surgery

  1. During pre anesthesia visit before conduction pre anesthesia checkup a base line level anxiety will be measured among both the group of patients.

    After this pre anesthesia examination will be conducted. The intervention group will be then asked to watch multimedia video information where as other group will be provided with verbal information only.

  2. Change in anxiety level will be measured at one hour before the surgery and eight hours after the surgery among the both the group using same scoring system.

Change in anxiety level will be assessed using the Hamilton anxiety rating scale which ranges from minimum 0 and maximum 56 (higher score means poor outcome high level of anxiety)
1) During pre anesthesia check up before providing verbal or multimedia information. 2) one hour before the surgery 3) 8 hours after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chitwan Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

July 5, 2021

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

May 10, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

patients Hamilton scores and data regarding the study will be provided.

IPD Sharing Time Frame

data will be available after the study is completed to only people who request to view the data

IPD Sharing Access Criteria

data will be shared only for academic purpose

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on Multimedia video information

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe