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NCT Number: NCT06631196

Jacobson's Progressive Muscle Relaxation Technique on 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.

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Key information

Conditions

Leukemia Anxiety Anxiety Disorders Children Fatigue Fatigue Related to Cancer Treatment Hematologic Diseases Hemic and Lymphatic Diseases Mental Disorders Neoplasms Neoplasms by Histologic Type Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eman Badr, Phds

CONTACT

[email protected]

01002347927

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Acronym: JPMRT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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