Developing play therapy based on resilience and Comparison of its effectiveness with cognitive behavioral play therapy on pain severity , sleep disturbance, resilience, improving parent- child interaction and parenting stress in children with functional abdominal pain
Determining the effectiveness of play therapy based on resilience and its comparison with cognitive behavioral play therapy on pain severity , sleep disorder, resilience, improving parent- child interaction, parenting stress , in children with functional abdominal pain
Design
Clinical trial with control group, , with 24 subjects, in a parallel groups, and random assignment by lottery to three groups
Settings and conduct
Play therapy sessions will be conducted in the Amin Hospital Specialist Clinic by a person with a valid educational credential in the field of play therapy.
Participants/Inclusion and exclusion criteria
1. Patients diagnosed with gastrointestinal functional abdominal pain by Pediatrician(baby).
2. Patients are satisfied with the research (parent - child).
3. Age range from 5 to 9 years (child).
Intervention groups
1. play therapy based on resilience
2- cognitive behavioral play therapy
3-Control (without intervention, intervention after completion of research)
Developing play therapy based on resilience and Comparison of its effectiveness with cognitive behavioral play therapy on pain severity , sleep disturbance, resilience, improving parent- child interaction and parenting stress in children with functional abdominal pain
Public title
Developing play therapy on severity pain, sleep disturbance, resilience, improving parent- child interaction and parenting stress in children with abdominal pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been diagnosed with gastrointestinal functional abdominal pain (child).
2. Patients are satisfied with the research (parent - child).
Age range from 5 to 9 years (child).
Exclusion criteria:
Patients who are in the acute phase of psychiatric disorders (eg, bipolar disorder, severe depression) (parent - child).
Patients who have acute physical symptoms that prevent them from attending treatment (parent - child).
Age
From 5 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Study participants will be selected by lottery and assigned randomly to the experimental and control groups by assigning a numeric identification code to each of their names.
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 Biomedical Research, Islamic Azad University, Isfahan Branch (Khorasgan)
Street address
Arghavanieh, Jey St., Esfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81595-158
Approval date
2018-06-03, 1397/03/13
Ethics committee reference number
IR.IAU..KHUISF.REC.1397.012
Health conditions studied
1
Description of health condition studied
Functional abdominal pain
ICD-10 code
R10.9
ICD-10 code description
Unspecified abdominal pain
Primary outcomes
1
Description
Severity of Pain
Timepoint
Before and after intervention
Method of measurement
Abdominal Pain Questionnaire (APQ-1977),
2
Description
Sleep Disorders
Timepoint
Before and after intervention
Method of measurement
sleep disturbance scale (SDS-1996)
3
Description
Resiliency
Timepoint
Before and after intervention
Method of measurement
children's resiliency scale
4
Description
Parent-Child Relationships
Timepoint
Before and after intervention
Method of measurement
Parent-Child Relationships scale (CPRS-1992)
5
Description
Parenting Stress
Timepoint
Before and after intervention
Method of measurement
Parental Stress Scale (SPS-1995)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: play therapy based on Resilience Including Emotion recognition training, Problem solving, self-esteem, optimism and connecting with friends through play- 8 weekly sessions of 2 hours(one session a week)
Category
Behavior
2
Description
Intervention group: play therapy based on cognitive-behavioral therapy Including Psycho-education, Self-monitoring, Coping skills training for children, (Deep breathing exercises, Progressive muscle relaxation, Guided imagery, Positive self-talk, Distraction and alternate activities, Self-reinforcement), Parent training, - 6 weekly sessions of 2 hours(one session a week)
Category
Behavior
3
Description
Control group: No intervention, Training after the end of the research