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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609801831051 Date of Registration: 04/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect of Nonpharmacological Approaches to Alleviate Pain, Anxiety and Stress in Pediatric Hemodialysis Patients
Official scientific title The Effect of Nonpharmacological Approaches to Alleviate Pain, Anxiety and Stress in Pediatric Hemodialysis Patients
Brief summary describing the background and objectives of the trial Hemodialysis is a stressful and painful procedure for children and may be associated with increased levels of pain, anxiety, and stress. Nonpharmacological approaches may provide safe and effective methods to alleviate these adverse experiences. This study aims to evaluate the effect of selected nonpharmacological approaches on pain, anxiety, and stress among pediatric patients undergoing hemodialysis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 15/07/2025
Actual trial start date 15/07/2025
Anticipated date of last follow up 15/07/2026
Actual Last follow-up date 15/07/2026
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combined nonpharmacological approaches Applied during each hemodialysis session, three sessions per week Throughout the hemodialysis treatment period, with assessment at pre-intervention, post-intervention, and one-month follow-up A combination of four non-pharmacological approaches was applied to children in the intervention group during hemodialysis sessions to alleviate pain, anxiety, and stress: rewarding brave behaviors, the "Steps in the Sky" distraction technique, the "Frog Breathing" relaxation technique, and listening to the Holy Qur'an. 40
Control Group Routine hemodialysis care Standard hemodialysis care without applied non-pharmacological approaches Throughout the hemodialysis treatment period, with assessment at pre-intervention, post-intervention, and one-month follow-up Children in the control group received routine hemodialysis care without the applied non-pharmacological approaches. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children of both sexes Children aged 8 to 18 years Children who are conscious and able to communicate Children not willing to participate in the study Children diagnosed with mental or psychiatric disorders Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Child: 6 Year-12 Year 8 Year(s) 18 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 24/02/2025 Research Ethics Committee Faculty of Nursing Capital University
Ethics Committee Address
Street address City Postal code Country
Faculty of Nursing Capital University Ain Helwan Cairo 11795 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain intensity, measured using a Numeric Rating Scale (NRS) Pre-intervention, immediately post-intervention, and at one-month follow-up
Secondary Outcome Anxiety level (measured using the Hamilton Anxiety Rating Scale, HAM-A) and perceived stress level (measured using the Perceived Stress Scale, PSS) Pre-intervention, immediately post-intervention, and at one-month follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni Suef University Hospital Nephrology Unit Ring Road, Beni Suef Beni Suef Egypt
Alhomiat Hospital Nephrology Unit Beni Suef Beni Suef Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rehab mostsfa mohamed mohamed Ain Helwan Helwan Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Helwan University Faculty of Nursing Ain Helwan, Helwan Cairo 11795 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rehab Mostafa Mohamed Mohamed rehab0158@gmail.com +201208373676 Beni Suef
City Postal code Country Position/Affiliation
Beni Suef Egypt Clinical Instructor
Role Name Email Phone Street address
Public Enquiries Rehab Mostafa Mohamed Mohamed rehab0158@gmail.com +201208373676 Beni Suef
City Postal code Country Position/Affiliation
Beni Suef Egypt Clinical Instructor
Role Name Email Phone Street address
Scientific Enquiries Rehab Mostafa Mohamed Mohamed rehab0158@gmail.com +201208373676 Beni Suef
City Postal code Country Position/Affiliation
Beni Suef Egypt Clinical Instructor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual de identified participant data will not be shared, as the dataset contains sensitive health information from a pediatric population. Aggregated results will be made available in the published article and thesis. Informed Consent Form,Study Protocol Not applicable, as individual participant data will not be shared Not applicable
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 26/08/2026 Adding the Adult age category (18 years) to align with the study's maximum age criterion, as requested in the review feedback. Child: 6 Year-12 Year, Adolescent: 13 Year(s)-17 Year(s) Child: 6 Year-12 Year, Adolescent: 13 Year(s)-17 Year(s), Adult: 18 Year(s)-44 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 26/08/2026 Uploading the ethics approval document as requested in the review feedback TRUE, Research Ethics Committee Faculty of Nursing Helwan University, Faculty of Nursing Helwan University Ain Helwan, Cairo, 11795, Egypt, , 24 Feb 2025, 0020225737359, dean.office@nursing.helwan.edu.eg, TRUE, Research Ethics Committee Faculty of Nursing Capital University, Faculty of Nursing Capital University Ain Helwan, Cairo, 11795, Egypt, , 24 Feb 2025, 0020225737359, dean.office@nursing.Capital.edu.eg, 44931_40259_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 26/08/2026 Updating the funding source name to reflect the actual name of the principal investigator, as requested in the review feedback. Self funded no external funding, Ain Helwan Helwan, Cairo, , Egypt, Self Funded, Rehab mostsfa mohamed mohamed, Ain Helwan Helwan, Cairo, , Egypt, Self Funded,