Clinical trial NCT06631196: Jacobson's Progressive Muscle Relaxation Technique on Children With Leukemia Undergoing Chemotherapy.
Official title: The Effect of Jacobson's Progressive Muscle Relaxation Technique on Anxiety and Fatigue Among Children With Leukemia Undergoing Chemotherapy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Leukemia
Children
Fatigue Related to Cancer Treatment
Anxiety
Keywords: Jacobson&amp;#39;s Progressive Muscle Relaxation Technique
Anxiety
Fatigue
Children
Leukemia
Chemotherapy
nursing care
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to determine the effect of Jacobson's progressive muscle relaxation technique on anxiety and fatigue among children with leukemia undergoing chemotherapy. The main research hypotheses are;

* Children with leukemia who receive Jacobson's progressive muscle relaxation technique exhibit less anxiety than those who don't receive it.
* Children with leukemia who receive Jacobson's progressive muscle relaxation technique exhibit less fatigue than those who don't receive it.

Researchers will compare Jacobson's progressive muscle relaxation technique with standardized nursing care on a child's anxiety and fatigue.


Eligibility criteria: Inclusion Criteria:

* Children diagnosed with leukemia and received chemotherapy sessions.
* Age ranged from 7 to 15 years.

Exclusion Criteria:

* other disorders such as neurological diseases, cerebrovascular accidents, or mental illness.

Primary outcomes:
measure: Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale:
timeFrame: before and after intervention.
Secondary outcomes:
measure: Spence Children's Anxiety Scale - Child (SCAS-Child)
timeFrame: before and after intervention.
Other outcomes:
measure: Socio Demographic and Medical Data of Children with leukemia Undergoing Chemotherapy Structured Interview Schedule
timeFrame: before intervention
Locations:
Study officials:
References:
citation: Sulistyawati, E., Allenidekania, A., & Gayatri, D. (2021). Effect of progressive muscle relaxation on sleep quality and side effects of chemotherapy in children with cancer: randomized clinical trial. Open Access Macedonian Journal of Medical Sciences, 9(T4), 300-308. https://doi.org/10.3889/oamjms.2021.5774
citation: Pouraboli B, Poodineh Z, Jahani Y. The Effect of Relaxation Techniques on Anxiety, Fatigue and Sleep Quality of Parents of Children with Leukemia under Chemotherapy in South East Iran. Asian Pac J Cancer Prev. 2019 Oct 1;20(10):2903-2908. doi: 10.31557/APJCP.2019.20.10.2903.
citation: Mohammed Ahmed Mohammed, E., Ali Ibrahim Almanzlawi, H., & Attia Abdel Naby Raslan, H. (2020). Effect of Progressive Muscle Relaxation on Pain and Fatigue among Post Cardiac Surgery Patients. Egyptian Journal of Health Care, 11(2), 736-745. https://doi:10.21608/ejhc.2020.180367
citation: Haggag, W, E., Soliman, H. (1997). The Arabic version of multidimensional fatigue inventory: reliability, validity and findings in three groups. Egyptian Journal of Psychiatry, 20(1), 85-97.
citation: Giri A, Tanaya K. (2019). Effect of Jacobson's progressive muscle relaxation exercise on anxiety among children diagnosed with leukemia admitted in selected hospital of Cuttack. International Journal of Health Sciences & Research, 9(2),151-155.
citation: Baccouche, K., Walha, A., Medhaffar, M., Kammoun, W., Ayadi, H., Moalla, Y., … Ghribi, F. (2017). Evaluation of Anxiety in Children with Acute Leukemia: A Prospective Study of 20 Cases. European Psychiatry, 41(S1), s131-s131. doi:10.1016/j.eurpsy.2017.01.1947
citation: Ali, N.S.( 2021). The Arabic version of Spence Children's Anxiety Scale - Child (SCAS-Child). Available from: https://www.scaswebsite.com/wp-content/uploads/2021/07/scas-child-arabic.pdf