A comparative study of the effect of music therapy with Jacobson's relaxation technique on the severity of fatigue and quality of life of lymphoma patients undergoing chemotherapy
Comparison the effect of music therapy with Jacobson's relaxation technique on the severity of fatigue and quality level of lymphoma patients
Design
It is a randomized cross-over clinical trial in which without blinding and randomly using a block method of four, the people referred to the above treatment center are equally divided into two test groups A (30 people) and B (30 people).
Settings and conduct
The mentioned plan is carried out in Shariati Hospital located in Tehran. Also, based on the nature of the intervention and its effect on other patients, all interventions will be performed individually and in a single room for each person
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range of 18 to 60 years, definitive diagnosis of lymph node cancer, willingness to use both music therapy and progressive muscle relaxation methods, and exclusion criteria: unwillingness to participate in the study.
Intervention groups
Eligible patients will be divided into two groups using random blocks. For group A, listening to one of the soothing songs of wordless music using hands-free and for group B, the Jacobson relaxation technique is performed, and the patient is asked to do the taught things for 4 weeks at home daily for 20 minutes. execute Questionnaires will be completed at the beginning and one week and four weeks after the start of the intervention. A wash-out month will be included and then the interventions will be implemented crosswise on the groups.
Main outcome variables
Fatigue,quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200926048842N5
Registration date:2023-07-10, 1402/04/19
Registration timing:prospective
Last update:2023-07-10, 1402/04/19
Update count:0
Registration date
2023-07-10, 1402/04/19
Registrant information
Name
Sajad Salehipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3237 3188
Email address
ssn.shahroud@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-11, 1402/04/20
Expected recruitment end date
2024-03-10, 1402/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of music therapy with Jacobson's relaxation technique on the severity of fatigue and quality of life of lymphoma patients undergoing chemotherapy
Public title
Comparison of the effect of music therapy with Jacobson's relaxation technique on the severity of fatigue and quality of life of lymphoma patients undergoing chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being aged between 18 to 60 years
A definitive diagnosis of lymph node cancer and its type (Hodgkin's and non-Hodgkin's) has been made by a hematologist and oncologist.
Receiving ABVD drug regimen in Hodgkin's lymphoma patients
Receiving drug regimen R-CHOP or R-EPOCH in non-Hodgkin's lymphoma patients
Being alert and trainable
No mental disorders
Not using muscle relaxants, sleeping pills and psychoactive drugs
Interested in both music therapy and progressive muscle relaxation
Absence of physical disorders such as (hearing and movement problems) and acute mental disorders
At least 3 months have passed since the person was diagnosed with cancer
Having a normal body mass index
Having hemoglobin of at least 8gr/dl
Exclusion criteria:
Refusal to continue participating in the study
Decreased level of alertness while studying
The occurrence of severe physical complications caused by the disease
Metastasis to other parts of the body
Implementation of less than four days a week and its non-compliance with the training given
death of the patient
suffering from diseases characterized by fatigue (multiple sclerosis, fibromyalgia, AIDS, joint rheumatism)
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by the available method. All patients with lymph node cancer referred to Shariati Hospital affiliated to Tehran University of Medical Sciences who meet the inclusion criteria will be included in the study. Then the selected patients are divided into two groups (A and B) in a crosswise manner. In this way, first of all, an envelope containing the name of the group will be prepared for the total number of people studied and randomly arranged, and with the gradual selection of people, one of the cards will be assigned to them, which will determine the individual's group. According to random sampling, the research samples will have an equal chance to be selected in two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
headquarters of Semnan University of Medical Sciences and Health Services, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-06-26, 1402/04/05
Ethics committee reference number
IR.SEMUMS.REC.1402.071
Health conditions studied
1
Description of health condition studied
lymphoma
ICD-10 code
C83.00
ICD-10 code description
Small cell B-cell lymphoma, unspecified site
Primary outcomes
1
Description
Level of quality of life
Timepoint
Before the start of the intervention, it will be completed at the end of the first and fourth week after the start of the intervention.
Method of measurement
The score given by the patient from the questionnaire (EORTC QLQ-C30) which is specific for cancer patients and measures 5 functional domains, 9 symptom domains and one general domain of quality of life. This questionnaire is based on a four-point Likert scale. Not at all (score 1), a little (score 2), a bit (score 3), very much (score 4). To calculate the score of each subscale, the score of each item related to that subscale is added together. To calculate the total score of the questionnaire, the scores of all questionnaire items are added together. The minimum and maximum score of this questionnaire is 30 and 126. The higher the score obtained from this questionnaire, the higher the quality of life and vice versa.
2
Description
Fatigue intensity
Timepoint
Before the start of the intervention, it will be completed at the end of the first and fourth week after the start of the intervention.
Method of measurement
The questionnaire (MFI) consists of 20 items and 5 subscales of general fatigue (4 questions), physical fatigue (4 questions), decreased activity (4 questions), decreased motivation (4 questions) and mental fatigue (4 questions), which It is used to measure fatigue. The scoring of the questionnaire is on a 5-option Likert scale from 1 = yes, completely true to 5 = no, completely false. Questions number 2, 5, 9, 10, 13, 14, 16, 17, 18, 19 are graded in reverse order and are graded as 5 completely correct to 1 completely incorrect. To get the overall score of the questionnaire, the scores of all items are added together. The total score of each field is 4-20 and the total score of fatigue determined by the sum of the scores of the fields can be between 20-100. A higher score indicates greater fatigue.
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: At first, in the first session of his intervention, the researcher appeared in the department one hour before the start of chemotherapy, then after obtaining informed consent from the patients of group A and their families, the demographic information checklist, the quality of life questionnaire (EORTC QLQ) -C30) and the fatigue measurement questionnaire (MFI) will be completed for them. Also, in order to follow up the intervention process, a contact number is obtained from all patients. In order not to affect the intervention on other patients, this treatment program is carried out individually in the ward's training room. At first, a music therapy program is performed for patients in group A. The process of performing the test (listening to music) will be explained to the patients. Patients will also be taught how to listen to music using hands-free and personal cell phones. If you do not have a hands-free device, it will be provided by the researcher for free. In this study, music therapy is performed in such a way that the patient leans on the chair, puts his hands comfortably on the thighs or the chair, and then closes his eyes slowly. In this case, the body is leaned on the chair in the most comfortable position and the patient is asked to take four deep breaths. According to his interest, the patient listens to one of the relaxing songs of wordless music that has a uniform and gentle rhythm and is far from any melodic and rhythmic emotions, for a period of 20 minutes using hands-free. The first session of music therapy will be done one hour before the patient's chemotherapy in the ward's training room and individually. Also, music audio files are provided to patients in the form of CDs, flash drives, or through a virtual network. Then the patients were asked to listen to one of the selected music according to their interest for 20 minutes every day for four weeks. In order to ensure the performance of music therapy on the scheduled days, a checklist is provided to the samples to record the day, time and duration of the process and, if not, the reason. In order to solve possible problems in the implementation of the music therapy process, during the research period, the researcher made phone calls with the research samples two days a week (with an interval of three days), to ensure the process of its implementation and the completion of the checklist. On the other hand, if the patient placed in group A does not perform the test less than four days a week and according to the determined method, he will be removed from the research. After four weeks of music therapy, the person will be asked not to do any Do not intervene. After this one month without intervention, first of all, the desired questionnaires are completed again, and Jacobson's relaxation technique is explained to the patient, and he is asked to, like music therapy, for four weeks, daily for 20 minutes, Do the Jacobson relaxation technique. Again, the desired questionnaires will be completed at the end of the first week and the fourth week after the start of the second intervention.
Category
Rehabilitation
2
Description
The second intervention group: In the first session of his intervention, the researcher appeared in the department one hour before the start of chemotherapy, then after obtaining oral and written informed consent from the patients and their families, the demographic information checklist, the quality of life questionnaire (EORTC QLQ- C30) and fatigue measurement questionnaire (MFI) will be completed for this group of patients under research. Also, in order to follow up the intervention process, a contact number will be obtained from all patients. For patients in group B, Jacobson's relaxation technique program will be performed at first. In this way, the implementation process (Jacobson's relaxation technique) will be explained one hour before the start of the patient's chemotherapy in the teaching room and individually. The first session of this technique is taught by the researcher in the presence of the patient and a member of the family for a period of 30 to 45 minutes in the mentioned medical centers. At the end of the first session, the patient is asked to perform the training and this stage will end by asking the patient and answering the questions about how to perform the technique. Then the patients were asked to do 20 minutes every day for four weeks; Do relaxation exercises according to the program at home. Before the intervention, the researcher will complete the theoretical and practical training of the relaxation technique in several stages under the supervision of a clinical psychologist. Performing the technique is as follows: at first, before performing the relaxation technique; The patient should take out all the extra items such as watches, bracelets, rings and all the items that can be separated and put them next to him, and then Jacobson's relaxation steps are taught to the patients as follows: At first, the patient closes his eyes. And as much as possible, he is in a calm state and should focus all his attention on his breathing. He is asked to take 5 deep breaths through his nose. And every time, empty your lungs completely of air and empty them slowly through your mouth. And at the same time, he repeats a relaxing word like (God, love, rain, rainbow and the like) in his mind. Then the patients should perform muscle contraction and expansion respectively for 14 muscle groups, including facial muscles (forehead, eyelids, jaws and lips), neck muscles, fingers, palms, forearms, arms, shoulders, back, waist, chest, abdomen, seat, It does thighs, calves, soles of the feet. The contraction of each muscle takes 5 seconds and its expansion takes 10 seconds, and also during muscle contraction; They should not be too tight and put pressure on themselves. Rather, it is sufficient to cause contraction in the usual level. After 15-20 minutes, ask the patient to take 5 deep breaths, slowly open your eyes and do not get up for a few minutes. The patient should not worry whether he has reached a deep level of relaxation or not; Let the relaxation happen to its own tune and when disturbing thoughts come, try to ignore them. Then the patients were asked to practice Jacobson's relaxation technique at home for 20 minutes every day for four weeks. Perform as they were taught. In order to ensure the implementation of the relaxation technique on the prescribed days, a checklist is provided to the samples to record the day, time and duration of the technique and, if not, the reason. In addition, a technique training CD is also provided to the patient. Also, in order to solve possible problems in the implementation of the technique, during the research period, the researcher made phone calls with the research samples two days a week (with an interval of three days), to ensure the process of the technique implementation and the completion of the checklist. Also, the families of these patients are requested to monitor the process of implementation of the technique by the patient at home and inform the researcher if any problem occurs. On the other hand, if the patient placed in group B does not perform the test less than four days a week and according to the determined method, he will be removed from the research. After four weeks of Jacobson relaxation technique, the person is asked not to do any intervention during the next month. After this one month without intervention, first of all, the desired questionnaires are completed again, and then the music therapy method is explained to the patient, and he is asked to use the relaxation technique of Jacobson, for four weeks, daily for 20 minutes. , perform music therapy. Again, the desired questionnaires will be completed at the end of the first week and the fourth week after the start of the second intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences, Shariati Hospital
Full name of responsible person
Sajad Salehipour
Street address
Shariati Hospital, in front of Faculty of Economics, Jalal Al Ahmad Street, North Kargar St.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mir Mohammad Khani
Street address
Central headquarters of Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sajad Salehipour
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 19, Alley 12, Lebanon Martyrs Street, Tehran Avenue
City
Shahroud
Province
Semnan
Postal code
3619676483
Phone
+98 23 3237 3188
Email
ssn.shahroud@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sajad Salehipour
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran St., Lebanon Martyrs St., Alley 12, No. 19
City
Shahroud
Province
Semnan
Postal code
3619676483
Phone
+98 23 3237 3188
Fax
Email
ssn.shahroud@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sajad Salehipour
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran St., Lebanon Martyrs St., Alley 12, No. 19
City
Shahroud
Province
Semnan
Postal code
3619676483
Phone
+98 23 3237 3188
Fax
Email
ssn.shahroud@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available