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Does Showing Video Information About Spinal Anesthesia Relieves Patient Anxiety?

Primary Purpose

Anxiety, Surgery, Spinal Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multimedia video information
Sponsored by
Chitwan Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Video Group

    non video group

    Arm Description

    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.

    patients in control group will be given verbal information regarding procedure, indication and complication, patient will be allowed to ask questions.

    Outcomes

    Primary Outcome Measures

    Change in anxiety
    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. 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)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 30, 2020
    Last Updated
    January 7, 2021
    Sponsor
    Chitwan Medical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04387487
    Brief Title
    Does Showing Video Information About Spinal Anesthesia Relieves Patient Anxiety?
    Official Title
    Effect of Multimedia Video Information in Relieving Anxiety Related to Spinalanesthesia. A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    June 30, 2021 (Anticipated)
    Study Completion Date
    July 5, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chitwan Medical College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety, Surgery, Spinal Anesthesia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Intervention name- multimedia video information Intervention details- 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.
    Masking
    ParticipantInvestigator
    Masking Description
    participant and investigators will be masked
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Video Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    non video group
    Arm Type
    No Intervention
    Arm Description
    patients in control group will be given verbal information regarding procedure, indication and complication, patient will be allowed to ask questions.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Multimedia video information
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in anxiety
    Description
    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. 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)
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Deepak Bhandari, MD
    Phone
    +9779851123608
    Email
    drbhandari.crc@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nabin Krishna Yadav, MD
    Phone
    +9779842163493
    Email
    korgiya@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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
    Citations:
    PubMed Identifier
    8315804
    Citation
    Hashimoto Y, Baba S, Koh H, Takagi H, Ishihara H, Matsuki A. [Anxiolytic effect of preoperative showing of "anesthesia video" for surgical patients]. Masui. 1993 Apr;42(4):611-6. Japanese.
    Results Reference
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