LeukemiaJPMRTNCT06631196
Jacobson's Progressive Muscle Relaxation Technique on Children With Leukemia Undergoing Chemotherapy.
A study testing Jacobson's PMRT in people with Leukemia and Children, run by Alexandria University.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Leukemia, Children, Fatigue Related to Cancer Treatment
- What is being tested?
- Jacobson's PMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children diagnosed with leukemia and received chemotherapy sessions.
- Age ranged from 7 to 15 years.
Who cannot join
- other disorders such as neurological diseases, cerebrovascular accidents, or mental illness.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Leukemia, Children, Fatigue Related to Cancer Treatment, Anxiety
- Being tested
- Jacobson's PMRT
- Keywords
- Jacobson's Progressive Muscle Relaxation Technique, Anxiety, Fatigue, Children, Leukemia, Chemotherapy, nursing care
- Medical subject headings
- Leukemia, Anxiety Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jacobson's PMRTProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Jacobson's PMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before and after intervention.
Secondary outcomes (1)
Spence Children's Anxiety Scale - Child (SCAS-Child)
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
Measured: before and after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631196
- Sponsor's protocol ID
- AU-20-4-294 (IRB00013620)
- Acronym
- JPMRT
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31653133Mohammed 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 at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Jacobson's Progressive Muscle Relaxation Technique on Anxiety and Fatigue Among Children With Leukemia Undergoing Chemotherapy.
- ClinicalTrials.gov ID
- NCT06631196
- Acronym / sponsor ID
- JPMRT / AU-20-4-294 (IRB00013620)
- Conditions
- Leukemia, Children, Fatigue Related to Cancer Treatment, Anxiety
- Keywords
- Jacobson's Progressive Muscle Relaxation Technique, Anxiety, Fatigue, Children, Leukemia, Chemotherapy, nursing care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –children will be subjected to standardized nursing care. |
| Interventional group (Jacobson's PMRT) | Experimental | Procedure: Jacobson's PMRTchildren will be subjected to the implementation of Jacobson's progressive muscle relaxation technique for children with leukemia undergoing chemotherapy. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children diagnosed with leukemia and received chemotherapy sessions.
- Age ranged from 7 to 15 years.
Key exclusion criteria (1 listed)
- other disorders such as neurological diseases, cerebrovascular accidents, or mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jacobson's PMRTeach 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. | Procedure or surgery | Interventional group (Jacobson's PMRT) |
Primary outcome
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
1 secondary outcome
Spence Children's Anxiety Scale - Child (SCAS-Child)
Time frame: before and after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Results publicationSulistyawati, 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
- Results publication: PubMed 31653133Pouraboli 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.
- Results publicationMohammed 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
- Results publicationHaggag, 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.
- Results publicationGiri 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.
- Results publicationBaccouche, 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
- Results publicationAli, 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Jacobson's PMRT in people with Leukemia and Children, run by Alexandria University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Badr, Phds (01002347927, eman.badr@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale: (time frame: before and after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06631196, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.