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.: PACTR202407894821147 Date of Approval: 17/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Mindfulness Practices versus Acupoints Stimulation on Anxiety, Fatigue and Sleep Quality in Children Undergoing Stem Cell Transplantation
Official scientific title Mindfulness Practices versus Acupoints Stimulation on Anxiety, Fatigue and Sleep Quality in Children Undergoing Stem Cell Transplantation
Brief summary describing the background and objectives of the trial Mindfulness practices are increasingly shown to be effective in improving pain, nausea, mood disturbance, fatigue, and anxiety, as well as increase positive affect in patients in the early post-transplant period. Also, acupoint stimulation has the advantages of relieving anxiety and fatigue and improving quality of sleep for cancer patients. Aim of the study: To compare the efficacy of mindfulness practices and acupoint stimulation on anxiety levels, fatigue and sleep quality in children undergoing stem cell transplantation. Design: A randomized controlled trail design was used.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 06/06/2024
Actual trial start date 10/06/2024
Anticipated date of last follow up 03/09/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL https://www.teamscopeapp.com/blog/6-repositories-to-share-your-research-data
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 created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group mindfulness group it will be performed for 15 minutes / two times per day for 7 consecutive days after first chemotherapy session during preparation period prior to stem cell transplant for children it will be performed for 15 minutes / two times per day for 7 consecutive days after first chemotherapy session during preparation period prior to stem cell transplant for children • The studied children were reevaluated regarding level of anxiety, fatigue severity and quality of sleep by using (Tool II, III, and IV) immediately after (seventh day) of the intervention and at the end of intervention (for one month before discharge) during early post-transplant recovery period for all children in the three groups . • For mindfulness intervention group: received usual care in addition to mindfulness practical sessions that performed for 15 minutes / two times per day for 7 consecutive days after first chemotherapy session during preparation period prior to stem cell transplant for children as the following: 1. Mindful movement / walking: the researcher invites children to bring awareness to the connection between their bodies and minds through focused attention and a repeated linking of their micro-movements with their breath. The child was trained to focus attention on the breath and the slow, intentional micro-movements of the upper body, legs, and feet with each step. 2. Mindful listening which focuses awareness on the coming and going of sound in the environment 3. Mindful seeing which is observing surroundings and noticing, with thoughtful attention, what captures visual attention 4. Mindfulness of breath by consciously focusing on the natural rhythm and pace of the breath and returning to it when the mind wanders by using 5-finger breathing by focusing attention on the breath for 5 cycles of in and out breathing, tracing each finger for each breath 5. Mindfulness of emotions: Noticing feelings and putting them into words emotion mapping where children were invited to write about or illustrate emotions and where they are feeling these emotions within their bodies through Worry box activity where children were invited to put their worries in writing and then place them in a container specifically designed to hold them with kindness. 30
Experimental Group Acupoints stimulation group Acupoints stimulation through finger acupressure will be applied on the selected Yintang and Shenmen acupoints that will be performed for 10 minutes (5 min for each point) / two times per day for 7 consecutive days after first chemotherapy session during preparation period prior to stem cell transplant for children The studied children will be reevaluated regarding level of anxiety, fatigue severity and quality of sleep by using (Tool II, III, and IV) immediately after (seventh day) of the intervention and at the end of intervention (for one month before discharge) during early post-transplant recovery period for all children in the three groups . Acupoints stimulation through finger acupressure was applied on the selected Yintang and Shenmen acupoints that performed for 10 minutes (5 min for each point) / two times per day for 7 consecutive days after first chemotherapy session during preparation period prior to stem cell transplant for children as the following: The three points was pressured for 15 minutes using the thumb in a rotating manner with a mean of 20 to 25 cycles per minute (Khoram etal., 2020) 30
Control Group control group they will receive usual care according to the unit protocol of care they will receive usual care according to the unit protocol of care control group 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged 7-17 years From both sexes Have the ability to follow the instructions The exclusion criteria were: Having hearing impairment Having history of psychological disorders (i.e., anxiety and stress) or sleep disorders Having injuries in/near the determined acupoints stimulation (i.e., face) Taking anxiolytics, hypnotic-sedative drugs in the past 12 hrs Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 7 Year(s) 17 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 06/06/2024 Scientific Research ethics committee faculty of nursing
Ethics Committee Address
Street address City Postal code Country
Elgeish street tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome State-Trait Anxiety Inventory for Children (STAIC-S) was developed by Spielberger (1972) and adopted by the researchers, to measure transitory anxiety state in children. It consists of 20 sentences related to children feeling at a particular time. Children asks for ratings of agreement on a 3-point scale using the stem “I feel…” for 20 items both indicative of the presence of anxiety (e.g., 1= not upset; 2= upset; 3= very upset) and reverse-worded (e.g., 1= very calm; 2= calm; 3= not calm) items. after intervention
Primary Outcome Fatigue Severity Scale (FSS) (Rossi et al., 2017): The FSS questionnaire developed by Krupp et al., 1989 and contains nine items Likert-scaled measure of fatigue severity and how it affects certain activities during the past week. Answers are scored on a seven-point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. after the intervention
Primary Outcome PROMIS Parent Proxy Short Form – Sleep Disturbance 8a (Forrest et al 2018): It is the 8-items form that assesses the sleep quality and perceived difficulties with getting to sleep or staying asleep in children and adolescents in the last 7 days. It included sleep quality, sleep onset, and sleep continuity. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating poor sleep quality and greater severity of sleep disturbance. The measure is completed by the parent of the children. Less than 60% good quality, 60 %%- less than 80 fair quality and 80% -100% poor quality After intervention
Secondary Outcome Physiological parameters: blood pressure, pulse and breathing rate. before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
stem cell unit at Tanta University Hospitals Elgeish street Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
all researchers makaa street tanta 31511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor faculty of nursing Elgeish street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Samar Mohamed Ads Elhyatem Ehmehlla Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samar Eldesoky Ads samar_eldesoky@nursing.tanta.edu.eg 00201553238428 elhayatem
City Postal code Country Position/Affiliation
elmehalla Egypt Lecturer of Pediatric Nursing
Role Name Email Phone Street address
Principal Investigator Nagwa Magor nagwa.magor@nursing.tanta.edu.eg 00201507174472 elshabia
City Postal code Country Position/Affiliation
elmehalla Egypt lecturer
Role Name Email Phone Street address
Principal Investigator Seham Elhalafawy seham.elhalafawi@nursing.tanta.edu.eg 00201018787624 makka street
City Postal code Country Position/Affiliation
tanta Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Sahar Wasfy Mahmoud Mahmoud saharmelika2020@gmail.com 00201023808867 Belshasha
City Postal code Country Position/Affiliation
Belshasha Egypt lecturer of pediatric nursing
Role Name Email Phone Street address
Public Enquiries Ahmed Bakr ahmed.bakr717@yahoo.com 00201098547169 bresha street
City Postal code Country Position/Affiliation
tanta Egypt acountant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification. Informed Consent Form,Study Protocol Immediately following publication. No end date. controlled access after approval of authors
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