Protocol summary

Study aim
Determining the effect of guided mental imagery on the intensity of anxiety and physiological indicators of the family of patient with head trauma hospitalized in the intensive care unit
Design
The third phase of a clinical trial with a control group, with parallel groups, which will be conducted after a Pilot study on a number of biological parents of 7-18 year old patients hospitalized in the intensive care unit.
Settings and conduct
This study will be conducted on the biological parents of patients aged 7 to 18 admitted to the intensive care unit of Pakdasht Martyrs hospital.
Participants/Inclusion and exclusion criteria
Biological parents of head trauma patients aged 7 to 18 years who were present at the time of sampling and did not participate in a similar research with guided mental imagery and had no history of drug addiction and were treated with neuropsychiatric drugs are not included in the study and if they do not reluctance to complete the study or the acute condition of the hospitalized child changes and the parents need to be present at his bedside, they will be excluded from the research.
Intervention groups
Intervention group, 12 to 24 hours after their child's hospitalization in the intensive care unit, and after measuring the physiological indicators and anxiety scores, they listened to the audio tape of guided mental imagery through headphones, and immediately after that, for the second time, the physiological indicators and anxiety scores are measured. The control group after the first round of measurements, rests on the bed for the equivalent time of playing the audio tape, and immediately after that, the second round of measurements is performed.
Main outcome variables
Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140721018550N12
Registration date: 2023-04-08, 1402/01/19
Registration timing: prospective

Last update: 2023-04-08, 1402/01/19
Update count: 0
Registration date
2023-04-08, 1402/01/19
Registrant information
Name
Nayyereh Raiesdana
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 3867
Email address
nr_dana@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of guided mental imagery on the intensity of anxiety and physiological indicators of the family of patient with head trauma hospitalized in the intensive care unit
Public title
The effect of guided mental imagery on the intensity of anxiety and physiological indicators of the family of a patient with head trauma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Simultaneous presence of both biological parents of the patient at the time of sampling Their child's age should be 7 to 18 years No history of participate in similar research with the guided mental imagery No history of drug addiction Not being treated with neuropsychiatric drugs at the time of the study
Exclusion criteria:
The acute change in the condition of the hospitalized and the need for the presence of the parents at his bedside
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 2
Each sample in this research includes both the biological father and mother of a person with a head injury
Randomization (investigator's opinion)
Randomized
Randomization description
Parents of head trauma patients hospitalized in the intensive care units of Pakhdasht Martyrs Hospital are included in the study using the available method. Then they are divided into two groups A and B using the Restricted Randomization method with blocks of six. In other words, out of every six parents who enter the study, 3 parents are randomly placed in group A and three parents in group B. The number of possible states of blocks of six is ​​20. Among these 20 blocks of six, according to the sample size, blocks of six are randomly selected and based on that, patients are assigned to two groups. The randomization method is as follows: (AAABBB, ABAABB, AABBAB,………….,BBBAAA) We assign a sampling number. For example: AAABBB→00-04 ABAABB→05-09 AABBAB→10-14 .. BBBAAA→95-99 Which is twenty groups and each group has 5 numbers, which is 5 sampling numbers for each block.
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
Ethics Committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical sciences, Basij Bolverd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Approval date
2023-03-13, 1401/12/22
Ethics committee reference number
IR.SEMUMS.REC.1401.335

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F09
ICD-10 code description
Unspecified mental disorders due to Known Physiologic Conditions

Primary outcomes

1

Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
Spielberger State-Trait Anxiety Inventory

Secondary outcomes

1

Description
Systolic and diastolic blood pressure
Timepoint
Before and after intervention
Method of measurement
ِDigital arm spyghmomanometer (OMRON brand)

2

Description
Pulse rate
Timepoint
Before and after intervention
Method of measurement
Pulse oximeter (Choicemed brand, ModelCN56)

3

Description
O2 saturation percentage
Timepoint
Before and after intervention
Method of measurement
Pulse oximeter (Choicemed brand, ModelCN56)

Intervention groups

1

Description
Intervention group: First, blood pressure, pulse and percentage of oxygen saturation are measured from the left arm while lying on the back. Then, Spielberger State-Trait questionnaire will be completed by each parent alone, and immediately after that, the guided imagery audio clip will be played for them through headphones, and immediately after it is finished, blood pressure, pulse and percentage Oxygen saturation will be measured for second time and the Spielberger State questionnaire will be answered by each parent.
Category
Other

2

Description
Control group: Control group: First, blood pressure, pulse and percentage of oxygen saturation are measured from the left arm while lying on the back. Then, Spielberger's State-Trait anxiety questionnaire will be completed by each parent alone, and immediately after that, subjects lying on the back for the time equivalent to applying the intervention for the intervention group, and immediately after that, blood pressure, pulse and percentage Oxygen saturation will be measured for second time and the Spielberger State questionnaire will be answered by each parent.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pakdasht Martyrs Hospital
Full name of responsible person
Anoushirvan Sadeghi
Street address
Khyber IV street, Khatun abad, 18th kilometer of Khavaran road, Pakdasht, Iran
City
Pakhdasht
Province
Tehran
Postal code
3391193111
Phone
+98 21 3644 2001
Fax
+98 21 3644 2001
Email
shpmc@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
ِDeputy of Research and Technology, Semnan University of Medical sciences, Basij Boulevard, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3345 1336
Email
majidmirmohammadkhani@yahoo.com
Web page address
https://SEMUMS.ac.ir
Grant name
---
Grant code / Reference number
---
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
10
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
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Associate Professor. faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th kilometer of Damghan road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
nr_dana@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Associate Professor.Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th Kilometer of Damghan road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
nr_dana@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Associate Professor.Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th kilometer of Damghan road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
nr_dana@yahoo.com

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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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