Jacobson's Progressive Muscle Relaxation Technique on Children With Leukemia Undergoing Chemotherapy.

NCT06631196 | Not Yet Recruiting DMC

• 1 other identifier: AU-20-4-294 (IRB00013620)
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Leukemia; Children; Fatigue Related to Cancer Treatment; Anxiety

Keywords

Jacobson's Progressive Muscle Relaxation Technique; Anxiety; Fatigue; Children; Leukemia; Chemotherapy; nursing care

Outcome Measures

Primary Outcomes (1)

• Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale:

  This tool was developed initially by (Smets et al., 1995) to assess fatigue for the subject. The scale comprised 18 items and 3 subscales which are; General Fatigue, Sleep/Rest Fatigue, and Cognitive Fatigue. The format, instructions, Likert response scale, and scoring method are identical to the PedsQL 4.0 Generic Core Scales, with higher scores indicating a better health-related quality of life (lower fatigue symptoms). A five-point Likert scale was used to evaluate the responses in which (zero= never a problem; one = almost never a problem; two= sometimes a problem; three= often a problem; four= almost always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale as follows: * 0 = 100-76 * 1 = 75-51 * 2 = 50-26 * 3 = 25-1 * 4= 0

  before and after intervention.

Secondary Outcomes (1)

• Spence Children's Anxiety Scale - Child (SCAS-Child)

  before and after intervention.

Other Outcomes (1)

• Socio Demographic and Medical Data of Children with leukemia Undergoing Chemotherapy Structured Interview Schedule

  before intervention

Study Arms (2)

control group

NO INTERVENTION

children will be subjected to standardized nursing care.

Interventional group (Jacobson's PMRT)

EXPERIMENTAL

children will be subjected to the implementation of Jacobson's progressive muscle relaxation technique for children with leukemia undergoing chemotherapy.

Procedure: Jacobson's PMRT

Interventions

Jacobson's PMRT PROCEDURE

each child in the intervention group will perform five sessions of Jacobson's PMRT. Each session lasted for 15-20 minutes under the supervision of the researcher.

Interventional group (Jacobson's PMRT)

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Related Publications (7)

• 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

  RESULT

• 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.

  PMID: 31653133 RESULT

• 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

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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

  RESULT

• 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

  RESULT

MeSH Terms

Conditions

Leukemia; Anxiety Disorders; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eman Badr, Phds

CONTACT

01002347927; eman.badr@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 8, 2024
• Study Start: November 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10