Determining the effect of self-care behaviors on the quality of life among children and adolescents with syncope
Design
An experimental, single blind, randomized study with 120 patients, with the control group, with parallel design
Settings and conduct
Participants will be selected from children and adolescents aged 6-18 years with syncope referred to Shahid Chamran Cardiovascular Hospital and Imam Hossein Children's Hospital in Isfahan, and then they will be divided into two groups of intervention and control. The participants will be kept blind to the received intervention. They will complete pre-test questionnaires and the intervention will be conducted on both groups. After the data is collected, self-care behavior programs will be explained for the children and adolescents and their parents through speech, question-answering, role-play, pamphlet, and booklet. Verbal persuasion will be done in two ways: Verbal encouragement during intervention and monthly follow-ups by telephone throughout the study. Six months after the intervention, the post-test self-report questionnaires will be completed by the participants.
Participants/Inclusion and exclusion criteria
Inclusion criterion:
Children and adolescents aged 6-18 years with syncope
Exclusion criteron:
Patients with major chronic medical problems
Intervention groups
Intervention group: Receiving routine, common and standard syncope commands, Handgrip & Arm Tensing-Leg Crossing training, Tilting Training.
Control group: Receiving routine, conventional and standard syncope commands, physical training for syncope control (Handgrip & Arm Tensing - Leg Crossing)
Main outcome variables
self-care behaviors and quality of life in patients with syncope; Prevention of syncope in children and adolescents
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150428021987N3
Registration date:2018-04-08, 1397/01/19
Registration timing:registered_while_recruiting
Last update:2018-04-08, 1397/01/19
Update count:0
Registration date
2018-04-08, 1397/01/19
Registrant information
Name
alireza ahmadi
Name of organization / entity
medical university of isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 3295
Email address
alirezaahmadi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care programs on the quality of life of 6-18 year old children and adolescents with syncope
Public title
The effect of Self-Care Behaviors on Quality Of Life
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of syncope disease by a specialist physician and having a positive Tilt test
being at the age of 6-18 years
The ability to perform physical maneuvers
Written consent from parents
Exclusion criteria:
Patients with syncope due to structural heart disease
Patients with Orthostatic Hypotension
Patients with Vascular Steal Syndrome
People with chronic diseases
Not being volunteer to participate in the study
Age
From 6 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly assigned to two groups using the random numbers table
Blinding (investigator's opinion)
Single blinded
Blinding description
After receiving explanations about the study and receiving informed consent from parents, children and adolescents and their parents will be blind to the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences; Hezajarib Street
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Approval date
2018-01-23, 1396/11/03
Ethics committee reference number
IR.MUI.REC.1396.2.125
Health conditions studied
1
Description of health condition studied
Vasovagal syncope
ICD-10 code
R55
ICD-10 code description
Syncope and collapse
Primary outcomes
1
Description
Total Quality of Life Score
Timepoint
Baseline and 6 months after intervention
Method of measurement
Quality of Life questionnaire (PedsQL)
2
Description
Physical Health Score
Timepoint
Baseline and 6 months after intervention
Method of measurement
Quality of Life questionnaire (PedsQL)
3
Description
Emotional Functioning Score
Timepoint
Baseline and 6 months after intervention
Method of measurement
Quality of Life questionnaire (PedsQL)
4
Description
School Functioning Score
Timepoint
Baseline and 6 months after intervention
Method of measurement
Quality of Life questionnaire (PedsQL)
5
Description
Social Functioning Score
Timepoint
Baseline and 6 months after intervention
Method of measurement
Quality of Life questionnaire (PedsQL)
6
Description
Psychosocial Health Score
Timepoint
Baseline and 6 months after intervention
Method of measurement
Quality of Life questionnaire (PedsQL)
7
Description
Self-care questionnaire Score
Timepoint
Baseline and 6 months after intervention
Method of measurement
Researcher made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving routine, common, and standard syncope commands, including increased fluid intake and consuming more salt in foods and Physical maneuver training Including Handgrip & Arm Tensing - Leg Crossing and tilt training including Standing with back against a wall
Category
Prevention
2
Description
Control group: Receiving routine, common, and standard syncope commands, including increased fluid intake and consuming more salt in foods and Physical maneuver training Including Handgrip & Arm Tensing - Leg Crossing
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Heart Center
Full name of responsible person
Dr. Alireza Ahmadi
Street address
Pediatric Cardiovascular Research Center, Cardiovascular Research Institute, Third Moshtagh Ave, Isfahan, Iran