Protocol summary

Study aim
Investigating and comparing effect of guided imagery and deep breathing on vital signs and sleep quality of children hospitalized in the pediatric department
Design
A clinical trial with a control group, with parallel groups, single-blind, randomized, on 75 patients and in general, with three groups; randomization with the table of random numbers
Settings and conduct
This research is a single-blind clinical trial study on children hospitalized in Imam Ali Hospital in Karaj. Blinding will be done on the researcher filling the questionnaires.hospitalized children will be randomly divided into three groups: control, play therapy, and storytelling.
Participants/Inclusion and exclusion criteria
Inclusion: children aged 6 to 12, admitted to the ward for at least 48 hours, staying in the hospital for at least 5 days, diagnosed disease, obtaining informed consent from the child's parents; Exclusion: the presence of cognitive, nervous and learning problems, the child's lack of consciousness, inability to participate in interventions and cancer
Intervention groups
In the guided imagery group, images are shaped through standard images and videos, storytelling and imagination, which will take place for 3 days in two shifts of the morning and the evening for 45 to 60 minutes. In the deep breathing group, after the child is properly taught, he/she is asked to do this. Meanwhile, the researcher starts counting with one hand and puts the other hand on the child's diaphragm to ensure the air flow.The control group will receive the usual hospital treatments.
Main outcome variables
level of sleep quality and vital signs, adherence rate to treatment among child

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220704055367N3
Registration date: 2022-11-04, 1401/08/13
Registration timing: prospective

Last update: 2022-11-04, 1401/08/13
Update count: 0
Registration date
2022-11-04, 1401/08/13
Registrant information
Name
Fatemeh Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 86701
Email address
fatemeh.abdi87@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-24, 1401/09/03
Expected recruitment end date
2023-04-14, 1402/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigation of the effect of deep breathing and guided imagery on sleep quality and vital signs in children admitted to the hospital: A Randomized Controlled Trial
Public title
Comparison of the effect of deep breathing and guided visualization in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 6 to 12 Hospitalization for at least 48 hours Staying in the hospital for at least 5 days A diagnosed disease Obtaining informed consent from the child's parents
Exclusion criteria:
The presence of cognitive, neurological or learning problems Having Cancer Child's lack of consciousness
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
By using a randomized table, children will be assigned to one of the three groups (guided imagery, deep breathing and control). Assignment Sequences are determined using a computer random number table (www.Random.com), and in order to hide the allocation, the opaque packets are numbered sequentially.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a blinded clinical trial. Therefore, blinding will be implemented in the evaluators who will analyze the study data. For this purpose, the questionnaires that will be completed by the researchers in all three groups, in the form of a contract between the researchers. Also, it will be specified with one of the English letters above it, which questionnaire was completed by the participants of which of the study groups; However, the evaluators of the data analysis will not be aware of the English letter of agreement between the researchers assigned to each group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Alborz University of Medical Sciences
Street address
Ethics committee office, Second floor, Safarian alley, 45 meters to Golshahr
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2022-10-22, 1401/07/30
Ethics committee reference number
IR.ABZUMS.REC.1401.194

Health conditions studied

1

Description of health condition studied
Meningitis
ICD-10 code
A87
ICD-10 code description
Viral meningitis

2

Description of health condition studied
Reye's syndrome
ICD-10 code
G93.7
ICD-10 code description
Reye's syndrome

Primary outcomes

1

Description
Sleep Quality Score
Timepoint
Before intervention and one week after intervention
Method of measurement
Pittsburgh Sleep Quality Index

2

Description
Vital signs
Timepoint
Before intervention and one week after intervention
Method of measurement
1-Blood pressure: by sphygmomanometer 2-Temperature: by thermometer 3-Pulse: counted for one full minute 4-Breathing: counted for one full minute.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Guided imagery takes place through standard video images, storytelling and imagination.In this way, the mentioned interventions will be played in the form of headphones for children within 18 to 20 minutes each time. This intervention take place in three days in two shifts of morning and evening. The content of the audio file includes appropriate and pleasant topics combined with soothing music so that the child can visualize it in his/her mind.
Category
Behavior

2

Description
Intervention group 2: After teaching the deep breathing technique in the form of pursed lips breathing, the child is asked to do this. Meanwhile, the researcher places one hand on the child's diaphragm to ensure the presence of air flow and starts counting with the other hand. To perform this procedure, the patient is asked to inhale and exhale in a ratio of 4:6. Patients are taught to inhale through the nose and count from one to four and exhale through the mouth and count from one to six. It will take 10-15 minutes.This intervention take place in three days in two shifts of morning and evening.
Category
Behavior

3

Description
Control group: Receiving routine intervention of the ward such as receiving drugs, similar to other hospitalized children who will not participate in the study and will not be exposed to deep breathing or guided imagery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Educational-Medical Center
Full name of responsible person
Fatemeh Abdi
Street address
Resalat crossroad
City
Karaj
Province
Alborz
Postal code
3154646695
Phone
+98 26 3254 6372
Email
emamali@abzums.ac.ir
Web page address
https://emamali.abzums.ac.ir/fa-IR/emamali.abzums.ac/5418/page/%D8%B5%D9%81%D8%AD%D9%87-%D8%A7%D8%B5%D9%84%DB%8C

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Street address
Alborz Univeirsity of Medical Sciences (ABZUMS), Northern Taleghani boulevard,Taleghani square
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
info@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
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
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Abdi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani Boulevard,Taleghani square ,Karaj,Iran
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3419 7000
Fax
Email
fatemeh.abdi87@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Abdi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of nursing, Eshteraki street, Baghestan BLVD, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3433 6007
Email
fatemeh.abdi87@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Abdi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani Boulevard,Taleghani square, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3419 7000
Fax
Email
fatemeh.abdi87@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data, such as information related to the main outcome and general demographic information can be shared.
When the data will become available and for how long
The access period starts 3 months after the results are published
To whom data/document is available
Doctors, nurses, midwives, researchers working in universities and medical centers and hospitals, clinical psychologists
Under which criteria data/document could be used
In order to use it for scientific purposes and by mentioning the source used and requesting the journal in which the article will be published.
From where data/document is obtainable
Communication through e-mail (if possible to share information from a legal and ethical point of view, such as sharing the primary outcome of the study) To receive information, contact the following email address: fatemeh.abdi87@yahoo.com In the case of sending letter with regard to the current study, the following postal address of the corresponding author is available: School of nursing, Eshteraki street, Takhti Park, Baghestan BLVD
What processes are involved for a request to access data/document
Finding the responsible author's email, stating the reason, complying with ethical and legal issues; In this case, a quick response will be given to the requester.
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