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

October 7, 2024 updated by: Alexandria University

The Effect of Jacobson's Progressive Muscle Relaxation Technique on Anxiety and Fatigue Among Children With Leukemia Undergoing Chemotherapy.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
children will be subjected to standardized nursing care.
Experimental: Interventional group (Jacobson's PMRT)
children will be subjected to the implementation of Jacobson's progressive muscle relaxation technique for children with leukemia undergoing chemotherapy.
Procedure: Jacobson's PMRT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale:
Time Frame: before and after intervention.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spence Children's Anxiety Scale - Child (SCAS-Child)
Time Frame: before and after intervention.

This tool was developed initially by Spence, S.H., (1997) to assess the severity of anxiety symptoms for the subject. The scale consists of six subscales: Separation Anxiety, Social Phobia, Obsessive Compulsive Problems, Panic/Agoraphobia, Generalized Anxiety/Overanxious Symptoms and Fears of Physical Injury.

Scores consist of a total raw score (range from 0 to 114) and six sub-scale scores, with higher scores indicating greater severity of anxiety symptoms. Sub-scales are computed by summing the following items:

  • Separation anxiety (items 5, 8, 12, 15, 16, 44)
  • Social phobia (items 6, 7, 9, 10, 29, 35)
  • Obsessive-compulsive (items 14, 19, 27, 40, 41, 42)
  • Panic/agoraphobia (items 13, 21, 28, 30, 32, 34, 36, 37, 39)
  • Physical Injury (items 2, 18, 23, 25, 33)
  • Generalized anxiety (items 1, 3, 4, 20, 22, 24) Items that are not scored in either the total score or the sub-scale scores are 11, 17, 26, 31, 38, 43, 45, and 46. They are not scored because they did
before and after intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Socio Demographic and Medical Data of Children with leukemia Undergoing Chemotherapy Structured Interview Schedule
Time Frame: before intervention

This tool will be developed by the researcher to assess the socio-demographic and medical data of children undergoing chemotherapy. It will include 2 parts:

Part I: Socio-demographic data: It includes age, gender, educational level, and residence.

Part II: Medical data of children: It includes onset of disease, type of leukemia, prescribed chemotherapy
before intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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
  • 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.
  • 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
  • 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.
  • 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.
  • 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
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-20-4-294 (IRB00013620)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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