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The Effect of Benson's Relaxation Technique on Anxiety, Depression and Pain in Patients Undergoing Brain Tumor Surgery Admitted to the Intensive Care Unit

Protocol summary

Study aim
Determining the Effect of Benson's Relaxation Technique on Anxiety, Depression and Pain in Patients Undergoing Brain Tumor Surgery Admitted to the Intensive Care Unit
Design
a clinical trial, with a control group, with a single intervention group, non blinded, simple randomization through even or odd random numbers placed in a sealed envelope, on 74 patients who are candidates for brain tumor surgery
Settings and conduct
The studied population are conscious patients admitted to the Neurosurgery Intensive Care Unit, who are candidates for craniotomy to remove a brain tumor in a non-emergency manner at Hazrat Rasool Akram Hospital in Tehran. Questionnaires, which include demographic characteristics of the patient, Hospital Anxiety and Depression Scale, and Visual Analogue Scale for pain, are completed in three times in the control and intervention groups (20 minutes after relaxation): 1. the evening of the day before the operation 2. Half an hour before the operation 3. 24 hours after the operation
Participants/Inclusion and exclusion criteria
The participants include full conscious patients over the age of 18 who are candidates for elective brain tumor surgery and have the ability to perform relaxation exercises. The non-entry criteria include sensory and motor disorders and a history of anxiety and mental illness.
Intervention groups
In this study, there are two control and intervention groups, the control group receives routine care in the ICU after brain tumor surgery. In the intervention group, in addition to routine care, the Benson's Relaxation Technique is performed in the evening before the operation, one hour before the operation and 24 hours after the operation.
Main outcome variables
Anxiety; Depression; Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240211060957N1
Registration date: 2024-02-26, 1402/12/07
Registration timing: prospective

Last update: 2024-02-26, 1402/12/07
Update count: 0
Registration date
2024-02-26, 1402/12/07
Registrant information
Name
Nayereh Habibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4475 2664
Email address
nayereh.habibi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Benson's Relaxation Technique on Anxiety, Depression and Pain in Patients Undergoing Brain Tumor Surgery Admitted to the Intensive Care Unit
Public title
The Effect of Benson's Relaxation Technique on Anxiety, Depression and Pain in Patients Undergoing Brain Tumor Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All brain tumor patients without a history of chemotherapy or radiotherapy who undergo brain tumor surgery for the first time Having the ability to perform relaxation exercises (not having neurological dysfunction in the form of numbness and immobility of organs) Full consciousness (score 15 according to the Glasgow Coma Scale) Not having a tracheal tube Stable vital signs Informed and voluntary consent of the patient
Exclusion criteria:
Having uncontrolled diabetes Having a history of anxiety and psychiatric diseases and taking psychiatric and anti-anxiety drugs Drug addiction
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are placed in the control or test group by a simple random method through even or odd random numbers placed in a sealed envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Shahed University
Street address
Shahed University, facing the holy shrine of Imam Khomeini, Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2024-02-05, 1402/11/16
Ethics committee reference number
IR.SHAHED.REC.1402.116

Health conditions studied

1

Description of health condition studied
Anxiety, Depression, Pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety score in Hospital Anxiety and Depression Scale
Timepoint
The evening of the day before the operation, half an hour before the operation, 24 hours after the operation
Method of measurement
Hospital Anxiety and Depression Scale

2

Description
Depression score in Hospital Anxiety and Depression Scale
Timepoint
The evening of the day before the operation, half an hour before the operation, 24 hours after the operation
Method of measurement
Hospital Anxiety and Depression Scale

3

Description
Pain score on Visual Analog Scale
Timepoint
The evening of the day before the operation, half an hour before the operation, 24 hours after the operation
Method of measurement
Visual Analog Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in the intervention group, in addition to the routine care in the ICU, perform the Benson's Relaxation Technique for 15 minutes in the evening of the day before the operation, one hour before the operation and 24 hours after the operation, under the supervision of the researcher. Benson's Relaxation Technique is taught to the patient as follows: 1- To be placed in a comfortable position in bed. 2- close the eyes slowly. 3- Focus on gradually relaxing the muscles, starting from the soles of the feet and progressing to the face, and keep them relaxed. 4- Inhale through the nose and exhale slowly through the mouth. 5- When he exhales, he should say a pleasant word that calms him down, such as "God" and continue to breathe naturally and easily. 6- Continue these exercises for 15 minutes. 7- After finishing work, sit quietly on the bed for a few minutes with eyes closed and then with eyes open. 8- Do not worry about whether you are successful in achieving a deep level of relaxation or not. Maintain a positive attitude and allow relaxation to occur at its own pace. When intrusive thoughts occur, try to ignore them and return to repeating "God".
Category
Rehabilitation

2

Description
Control group: Patients receive routine care in the ICU and no intervention is performed for the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrate Rasool Akram Hospital
Full name of responsible person
Mohsen Nabiuni
Street address
Hazrate Rasool Akram Hospital, Maziar Mansoori Ave., Satar Khan Ave.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2481
Email
Rasoolhospital@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Shahriyar Bijani
Street address
Shahed University, facing the holy shrine of Imam Khomeini, Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 3565
Email
publicrelation@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Nayereh HABIBI
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
4th flour, No.12, Behzadi Alley, Yas Town, Koohak Avenue, Golestan Town
City
Tehran
Province
Tehran
Postal code
1493763885
Phone
+98 21 4475 2664
Email
nayereh.habibi@shahed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Nasrin Alaee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite Holy Shrine of Imam Khomeini, Khalij Fars Expressway,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
331911865
Phone
+98 21 5121 2130
Email
alaei@shahed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Nayereh Habibi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
4th flour, No.12, Behzadi Alley, Yas Town, Koohak Avenue, Golestan Town
City
Tehran
Province
Tehran
Postal code
1493763885
Phone
+98 21 4475 2664
Email
nayereh.habibi@shahed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Dissertation and article
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Health researchers
Under which criteria data/document could be used
For doing researches
From where data/document is obtainable
Researcher
What processes are involved for a request to access data/document
Sending e-mail documents showing activity in the field of health.
Comments
After collecting the data and analyzing the findings, the publication of the findings will be done by writing a thesis and an article.
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