Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202107755265445 Date of Approval: 05/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Play Therapy on Level of Stress Among School age Children Admitted in Nekemte Specialized Hospital
Official scientific title Effectiveness of Play Therapy on Level of Stress Among School age Children Admitted in Nekemte Specialized Hospital
Brief summary describing the background and objectives of the trial Hospitalization is the disruption of the lifestyle of children and their families. The change from home to hospital environment creates stress for children of all ages. Play therapy promotes healing and helps the child to cope with stressful experience. Therapeutic play is the specialized play activities by which children act out or expresses their unconscious feelings. It is a central mechanism in which children cope such as hospitalization. Hospitalization to any child is a very unpleasant and traumatic experience hospitalized children require more than recreational play because, illness and hospitalization constitute crisis in a child’s life and since these situation are brought with overwhelming stresses, children need to play out their fears and anxieties as a means of coping with these stresses. Therapeutic play during hospitalization aims to promote physical well-being and emotional relief from the stress caused by disease and hospitalization. Play therapy, might be one of the demanding supportive treatment of hospitalized children particularly in critically resource limited settings like Ethiopia where standard services of hospitals are also not to the expectation of hospitals as a healing environment. To the best of our knowledge, there has been no study done regarding the effect of play therapy on the level of stress among hospitalized children in Ethiopian hospitals including this study area. The aim of this study was to assess the level of stress encountered by School age children hospitalized and evaluate the effectiveness of play therapy on the level of stress among hospitalized school age children at Nekemte Referral hospital. To undertake this study we will use the Quasi experimental pre-test -post-test design. A total of 104 School children (experimental -52 and control-52) aged between 8-12 years will be selected by using non probability convenient sampling technique.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/08/2019
Actual trial start date 01/08/2019
Anticipated date of last follow up 19/08/2021
Actual Last follow-up date 31/08/2021
Anticipated target sample size (number of participants) 104
Actual target sample size (number of participants) 104
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Play therapy Not applicable For 4 days Stress level will be measure for both experimental and control groups of hospitalized children on the first day of admission after routine treatment begins. Then, experimental group will be provided an opportunity to engage in a specialized play known as "play therapy" starting from 2nd day of admission for 1 hours and for 3 consecutive days of during hospitalization after which their stress level is to be measured again on the 4th day to see the effects of play therapy on their stress level. 52
Control Group No Play therapy 4 days We will measure stress level up on admission(1st day) and deny this group an opportunity to engage in play therapy that means they continue with their hospital treatment and care with out play therapy. On the fourth day of their hospitalization, their stress level will be measured together with the experimental group using same level of stress measurement scale. 52 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- school aged children (8 and 12 years) - stayed in the hospital for at least 24-48 hours - have been treated with at least one peripheral intravenous puncture. - children who were physically handicapped, - those with diagnoses pertaining to neurological - cognitive disorders and with critical condition, - who had intellectual disability were excluded from this study. Child: 6 Year-12 Year 8 Year(s) 12 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/10/2018 Wollega University Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Nekemte/07 Nekemte 395 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Difference of Final Stress Level between the Two Groups At discharge from hospital
Secondary Outcome Stress level with out play therapy At discharge from hospital
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nekemte Specialized Hospital Nekemte, 07 Nekemte 395 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Wollega University Nekemte, Ethiopia Nekemte 395 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wollega University Nekemte/07 Nekemte 395 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Dr. Vasanthakunari Nekemte, Ethiopia Nekemte 395 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Vasanthakunari S. vasanhar@yahoo.com +251904018640 Nekemte/03
City Postal code Country Position/Affiliation
Nekemte 395 Ethiopia Wollega University Institute of Health Sciences
Role Name Email Phone Street address
Public Enquiries Ashenafi Woyessa ashexman2015@gmail.com +251922183065 Nekemte/03
City Postal code Country Position/Affiliation
Nekemte 395 Ethiopia Wollega University Institute of Health Sciences
Role Name Email Phone Street address
Scientific Enquiries Ashenafi Woyessa ashexman2015@gmail.com +251922183065 Nekemte/03
City Postal code Country Position/Affiliation
Nekemte 395 Ethiopia Wollega University Institute of Health Sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results going to be reported in this article, in text, tables, figures, and appendices will be provided soon after publication. In addition, we will make Statistical analysis plan and informed consent available. Informed Consent Form,Statistical Analysis Plan 1 year All aspects of data will be available from investigators on a reasonable request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information