AnxietyNCT04387487
Does Showing Video Information About Spinal Anesthesia Relieves Patient Anxiety?
A study testing Multimedia video information in people with Anxiety and Surgery, run by Chitwan Medical College.
Trial summary
Our primary aim is to compare the effect of pre-operative multimedia video information on perioperative anxiety and hemodynamic parameters. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Surgery, Spinal Anesthesia
- What is being tested?
- Multimedia video information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 5 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Multimedia video information
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia video informationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Video Group | Experimental | 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. Receives: Behavioral: Multimedia video information |
| non video group | No intervention | patients in control group will be given verbal information regarding procedure, indication and complication, patient will be allowed to ask questions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1) During pre anesthesia check up before providing verbal or multimedia information. 2) one hour before the surgery 3) 8 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Mar 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion5 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chitwan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Deepak Bhandari, Chitwan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387487
- Sponsor's protocol ID
- CMC001
- Status last verified
- Jan 2021
- First submitted
- 30 Apr 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: patients Hamilton scores and data regarding the study will be provided.
Publications
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.
PubMed 8315804
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multimedia Video Information in Relieving Anxiety Related to Spinalanesthesia. A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04387487
- Acronym / sponsor ID
- CMC001
- Conditions
- Anxiety, Surgery, Spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chitwan Medical CollegeUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 5 Jul 2021 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Video Group | Experimental | Behavioral: Multimedia video informationVideo 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. |
| non video group | No intervention | –patients in control group will be given verbal information regarding procedure, indication and complication, patient will be allowed to ask questions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients refusing to give consent for the study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimedia video informationDuring 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. | Behavioural | Video Group |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Background: PubMed 8315804Hashimoto 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.
- Individual participant dataSharing planned: Yes. patients Hamilton scores and data regarding the study will be provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Multimedia video information in people with Anxiety and Surgery, run by Chitwan Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deepak Bhandari, MD (+9779851123608, drbhandari.crc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04387487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.