Does Showing Video Information About Spinal Anesthesia Relieves Patient Anxiety?

NCT ID: NCT04387487

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-07-05

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 .

Conditions

Anxiety; Surgery; Spinal Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Multimedia video information

Intervention Type: BEHAVIORAL

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.

non video group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chitwan Medical College

OTHER

Sponsor Role: lead

Responsible Party

Dr Deepak Bhandari

Consultant Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Deepak Bhandari, MD

Role: CONTACT

drbhandari.crc@gmail.com

+9779851123608

Nabin Krishna Yadav, MD

Role: CONTACT

korgiya@gmail.com

+9779842163493

References

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.

Reference Type: BACKGROUND

PMID: 8315804 (View on PubMed)

Other Identifiers

CMC001

Identifier Type: -

Identifier Source: org_study_id