Thalassemia in ChildrenNCT05730374
Benson's Relaxation Technique, Music Therapy for Children With Thalassemia
A study testing Benson's Relaxation technique and Music therapy in people with Thalassemia in Children, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of the present study is to determine the effect of Benson's relaxation technique versus music therapy on physiological parameters and stress of children with thalassemia during blood transfusion. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Thalassemia in Children
- What is being tested?
- Benson's Relaxation technique and Music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 30 Apr 2023
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- preschool stage
Who cannot join
- Free from any neurological disorders.
- Free from major congenital malformations.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
the Hematology Out-Patient Clinic of the Children's University Hospital at El-Shatby
Alexandria
About this study
Official title: Effect of Benson's Relaxation Technique Versus Music Therapy on Physiological Parameters and Stress of Children With Thalassemia During Blood Transfusion
The aim of the present study is to determine the effect of Benson's relaxation technique versus music therapy on physiological parameters and stress of children with thalassemia during blood transfusion.
Read the detailed description
Thalassemia is the most common hematological disease in Egypt and the world that is transmitted by parents to their children and has no definitive cure. It means a group of hereditary blood diseases caused by defects haemoglobin (Hb) synthesis that results from an alteration in the gene responsible for producing globin chains leading to alteration in the rate of its production .
Generally in worldwide, There are about 300 million thalassemia patients, 55 million of whom live in Southeast Asia . In Egypt, beta-Thalassemia represents a major public health problem. It is reported that the carrier rate is between 9 to 10% of the population. It has been estimated that one thousand children out of 1.5 million live births are born each year suffering from thalassemia. In spite of optimal treatment being available, only a few children can afford it. Unfortunately, most children suffer from complications of blood transfusions, mainly transfusion transmitted viral infections and iron overload. Prevention by carrier detection and prenatal diagnosis is needed in populations with high incidence of the disease, such as Egypt.
The most severe form is the β-thalassemia major, which is characterized by a severe microcytic, hypochromic anemia (Cooley's anemia), whose symptoms appear usually within the first 2 years of life due to iron overload. Chronic iron overload can occur in children with beta-thalassemia as may need blood transfusions throughout their life. Iron overload can lead to growth retardation, pallor, poor appetite, and often jaundice; as well as hinder sexual development during the adolescent period and dysfunction of organs, such as heart, pancreas, and endocrine glands.
When the storage capacity of the body is exceeded, iron remains in free form. The formation of hydroxyl free radicals can be catalyzed by this free iron, leading to damage of cell membranes and protein denaturation. Ultimately, tissue damage occurs which can lead to significant levels of morbidity and mortality. Iron chelation helps prevent complications of iron overload due to repeated blood transfusion. Indeed, the most common complication of beta-thalassemia that leads to death is organ failure, in children taking regular blood transfusions and no appropriate iron chelation. Elevated liver iron concentrations (LICs) and serum ferritin levels can manifest within 1-2 years of starting regular blood transfusions. Children with thalassemia whose serum ferritin level is more than 2500 ng/mL or LIC value is more than 15 mg Fe/kg dry weight are at high risk of development of cardiac diseases such as cardiomyopathy.
Significant advances in treatment modalities and improved clinical management have led to a substantially higher life expectancy of these children. Children with thalassemia major have good survival but little is known about their psychological status. children are less able to voice their concerns and are more vulnerable than adults.
Today, with the help of existing therapies and the use of new drugs to improve iron overload control and timely initiation of treatment, the disease has become a chronic disease and life expectancy in these children has increased. However, repeated blood transfusions and long-term use of iron-chelating drugs affect other aspects of these children' lives and significantly affect their general health, mental health, and quality of life, and their families.
Thalassemia can cause different physiological, emotional, social, financial and behavioral problems that affect the life of both patients and their families, its effects are stronger particularly during school age and adolescence. It can greatly affect the sense of autonomy and mental health. Children with thalassemia major experience a lot of stress throughout their lives which constituted 18.8 %. Successive blood tests for fatigue, fatigue from successive blood transfusions, and subcutaneous injections of iron chelators, in addition to the body, irritate the souls of these patients. So much so that most of these patients also have mental disorders. It was described the fear and anxiety caused by injections in these children as the most difficult aspect of their illness.
Physiological changes occur when a person is threatened with illness, trauma, or stress. The physiological response to the stressor in the cardiovascular system increases blood pressure, changes the number of pulses and respiration, increases oxygen saturation, and increases the risk of arrhythmias. Therefore, it is very important to find an effective solution that is also cost-effective for clinical use.
Stress can be defined as any uncomfortable or agonizing emotional experience associated with changes in behavior as well as biochemical and physiological changes or in simple words we can say it is a feeling of being worried or overwhelmed. It can affect anyone regardless of age or gender of person and result in both physical as well as psychological health issues. Stress among children with thalassemia can be attributed to number of reasons like frequent treatment procedures and hospital visits, decreased life expectancy, expected complications from disease or treatment procedures and the monetary burden on parents. Also, the long painful treatment sessions such as to remove iron as iron overload being a complication of frequent blood transfusions, and an eight hour long painful procedure when injecting chelators by chelation pump is carried out, adding to the stress factors.
Unlike pharmacological treatments, complementary therapies in addition to cost effective, have no serious side effects or drug interactions, they are easy to perform, and well accepted by the patient. It is important to pay attention to additional therapies in the sense that can be performed by nurses without the need for a doctor's prescription, as well as to pave the way for nurses to gain professional independence.
Relaxation is one of the best complementary treatment strategies to decrease stress and mental disorders of the patients in order to improve their physical, psychological, and social functions. Moreover, relaxation increases the secretion of endorphins or analgesic hormone, but reduces the secretion of adrenaline hormone. In the present study, relaxation refers to one of the methods of concentration which is introduced due to its ease of learning and teaching. It was carried out in 4 stages: providing a relaxed environment, being in an appropriate physical position, concentration and creation of an inactive state. Creation of a calm environment, reduce muscle tension and focus by focusing on one word, increasing a person's attention, reducing the number of breaths and lactate in the blood can be occurred in Benson muscle relaxation due to lack of muscle stiffness, number of breaths, pulse and blood pressure are not increased and cardiac output is not increased.
So Benson relaxation therapy, as well as other relaxation techniques, that may cause a decrease in physical and psychological stress, which conceptually can decrease epinephrine, decrease cortisol, decrease glucagon and decrease thyroid hormone. All of these have a positive effect on reducing stress levels. Reduction in stress levels and the attainment of a relaxed condition in patients have positive effect on reducing stress levels. Therefore, various efforts were made to make patients comfortable and remain relaxed.
In addition to the Benson relaxation techniques described above, music therapy is another non-pharmacological methods that is believed to provide a relaxing effect on the patient and it considered to help reduce and even overcome psychological disorders and discomforts such as anxiety, stress, depression, and so on. Music therapy can be defined as the prescribed and organized use of music or its activities to change the maladaptive state in order to help clients achieve therapeutic goals. Music reduces stress by distracting and reducing a person's focus on stressful stimuli. Physicians can use it to reduce stress in children undergoing treatment or those with the possibility of further treatment. Due to the fact that therapeutic music has no side effects, in addition to this, it is easy, cheap, and safe and can be accepted by the client. Numerous studies have examined the effect of music therapy on reducing stress levels and vital signs.
- Conditions
- Thalassemia in Children
- Being tested
- Benson's Relaxation technique, Music therapy
- Keywords
- Benson's Relaxation, Music Therapy, Stress, Thalassemia
- Medical subject headings
- Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benson's Relaxation techniqueBehavioural
Each child in the study group had an individual interview with researchers, who demonstrated the Benson relaxation technique while teaching them. The child was then asked to demonstrate it. sit quietly in a comfortable position in separate room., close eyes, deeply relax all muscles, beginning at the feet and progressing up to the face and breathe through nose. Become aware of breathing pattern. As breathes out, say the word one silently to child. For example, breathe in, and then out, say one, in and out, and repeat one. Breathe easily and naturally. It is Continue for 10 minutes and repeated two times.
Music therapyBehavioural
- The child lessen to a Mozart's music, which is played before and throughout the blood transfusion procedure. Ambient noise can be reduced by using headphones. As a result, it is easier to see how the intervention has succeeded.
- This intervention was done using an MP3 player during the blood transfusion procedure and immediately following the completion of the intervention to prevent the transmission of infections headphones were cleaned with disinfectant after each -use.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | children with thalassemia will receive only routine care of hospital during blood transfusion. |
| Benson's Relaxation Group | Experimental | children with thalassemia will receive Benson's relaxation intervention beside routine care of hospital during blood transfusion Receives: Behavioral: Benson's Relaxation technique |
| Music Therapy Group | Experimental | children with thalassemia will receive music therapy intervention beside routine care of hospital during blood transfusion. Receives: Behavioral: Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tool I: Characteristics of Children with Thalassemia and Their Physiological Parameters Assessment Sheet:
This tool was developed by the researcher after reviewing the literature to assess the characteristics of children with thalassemia and their parameters. It includes two parts:Part One: children's characteristics: age, sex, and medical history. level of education, place of residence, Part Two: children's physiological parameters: respiratory rate, heart rate, and O2 saturation.
Measured: children's characteristics will be assessed initially, pre-procedure. physiological parameters of children will be assessed as the following; • "Baseline, pre-blood transfusion procedure" • "During the blood transfusion procedure" • "Immediately after th
Secondary outcomes (1)
Tool II: Observational Scale of Behavioral Distress:
This tool will be modified in this study to assess children's behavioral reactions to stress during a blood transfusion. It consists of an eleven-item revision of the Procedure Behavior Rating Scale, which depend on the Self-Report Measures of Fear. Children will be asked to rate "how scared" could be felt about their planned blood transfusion. Three faces were employed on a "face" scale, with the "happy" face denoting "not at all scared" and scored with 1, and the "sad" face denoting "very scared", and scored with 3. Total score of tool was ranged between 11 to 33. Children' perceived stress level will categorized as follows:
- Mild level of stress → 11-17.
- Moderate level of stress →18-25.
- Severe level of stress →26-33.
Measured: Children's behavioral reactions to stress will be assessed as the following;• "Baseline, pre-blood transfusion procedure" • "During the blood transfusion procedure" • "Immediately after the blood transfusion procedure"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Aug 2022
- Primary completion28 Feb 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Thalassemia in ChildrenStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730374
- Sponsor's protocol ID
- BRT
- Status last verified
- Jan 2023
- First submitted
- 24 Jan 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-said S, Darwish A, Abdelrahman D. Stress, anxiety and depression among adolescents suffering from thalassemia. Port Said Scientific Journal of Nursing, 2021;8(3): 149-61. DOI: 10.21608/PSSJN.2021.78945.1112 https://pssjn.journals.ekb.eg/article_212190.html
El-Shanshory MR, Sherief LM, Hassab HM, Ragab SM, Yahia S, Mansour AK, Ahmed AS, Abdou SH, Helmy AM, Watany MM, Gad ALllah AM, Guindy MA, Mourad ZI, Soliman MA, El-Farahaty RM, El-Dahtory F, Darwish A, Elmabood SA, Kabbash IA, Saied SM. Prevalence of iron deficiency anemia and beta thalassemia carriers among relatives of beta thalassemia patients in Nile Delta region, Egypt: a multicenter study. J Egypt Public Health Assoc. 2021 Oct 11;96(1):27. doi: 10.1186/s42506-021-00088-9.
PubMed 34633587Hisam A, Khan NUS, Tariq NA, Irfan H, Arif B, Noor M. Perceived stress and monetary burden among thalassemia patients and their caregivers. Pak J Med Sci. 2018 Jul-Aug;34(4):901-906. doi: 10.12669/pjms.344.15420.
PubMed 30190750Jajhara I, Choudhary G, Singh J, Chachan V, Kumar A. A study on quality of life among thalassemic children aged 8 to 18 years. Int J Contemp Pediatr 2021; 8: 1667-74. DOI: https://dx.doi.org/10.18203/2349-3291.ijcp20213727.
Kaviani M, Bahoosh N, Azima S, Asadi N, Sharif F, Sayadi M. The effect of relaxation on blood sugar and blood pressure changes of women with gestational diabetes: a randomized control trial. Iranian journal of diabetes and obesity, 2014; 6(1): 14-22
Panigrahi M, Swain TR, Jena RK, Panigrahi A, Debta N. Effectiveness of Deferasirox in Pediatric Thalassemia Patients: Experience from a Tertiary Care Hospital of Odisha. Indian J Pharmacol. 2020 May-Jun;52(3):172-178. doi: 10.4103/ijp.IJP_68_18. Epub 2020 Aug 4.
PubMed 32873999Seifi L, Najafi Ghezeljeh T, Haghani H. The effects of benson relaxation technique and nature sound's on anxiety in patients with heart failure. Nurs Midwifery J. 2017; 15 (2):147-158. http://unmf.umsu.ac.ir/article-1-3036-en.html
Sheikhi, A. R., Naderifar, M., Abdullahi M. A, Mastalizadeh, H., Sheikhi, H. R.The Effect of Music Therapy on the Anxiety Level of Children with Thalassemia Major under Blood Transfusion. Arch Pharma Pract 2020; 11(S4):66-9. https://www.researchgate.net/publication/348592642
Foley V. Clinical Measurement. In: Delves -Yates, C. (Ed.) Essentials of Nursing Practice. London: Sage Co., 2015; 349-378.
Packyanathan JS, Lakshmanan R, Jayashri P. Effect of music therapy on anxiety levels on patient undergoing dental extractions. J Family Med Prim Care. 2019 Dec 10;8(12):3854-3860. doi: 10.4103/jfmpc.jfmpc_789_19. eCollection 2019 Dec.
PubMed 31879625Poorolajal J. Effect of Benson relaxation technique on the preoperative anxiety and hemodynamic status: A single blind randomized clinical trial, 2017; 17 (1): 33 - 38
Abd Elgwad F. Relaxation Therapy, Preeclampsia Effect of Benson's Relaxation Therapy on Stress and Physiological Parameters among Women with Preeclampsia. ASNJ, 2021;.23 (1) :63-74.
Ali Mansouri. Evaluation of the effect of foot reflexology massage on vital signs and anxiety after blood transfusions in children with thalassemia. Bali Medical Journal, 2017; 6(3) : 623-629 ISSN.2089-1180, E-ISSN.2302-2914444444
Salehipour S , Ghaljeh M .The Effect of Benson RelaxationTechnique on Anxiety and Aggression in Patients with Thalassemia Major: a Clinical Trial Study. P J M H S, 2021; 15( 3): 753.
Wu PY, Huang ML, Lee WP, Wang C, Shih WM. Effects of music listening on anxiety and physiological responses in patients undergoing awake craniotomy. Complement Ther Med. 2017 Jun;32:56-60. doi: 10.1016/j.ctim.2017.03.007. Epub 2017 Mar 31.
PubMed 28619305
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Benson's Relaxation Technique Versus Music Therapy on Physiological Parameters and Stress of Children With Thalassemia During Blood Transfusion
- ClinicalTrials.gov ID
- NCT05730374
- Acronym / sponsor ID
- BRT
- Conditions
- Thalassemia in Children
- Keywords
- Benson's Relaxation, Music Therapy, Stress, Thalassemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 15 Feb 2023 (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 aim of the present study is to determine the effect of Benson's relaxation technique versus music therapy on physiological parameters and stress of children with thalassemia during blood transfusion.
Detailed description
Thalassemia is the most common hematological disease in Egypt and the world that is transmitted by parents to their children and has no definitive cure. It means a group of hereditary blood diseases caused by defects haemoglobin (Hb) synthesis that results from an alteration in the gene responsible for producing globin chains leading to alteration in the rate of its production .
Generally in worldwide, There are about 300 million thalassemia patients, 55 million of whom live in Southeast Asia . In Egypt, beta-Thalassemia represents a major public health problem. It is reported that the carrier rate is between 9 to 10% of the population. It has been estimated that one thousand children out of 1.5 million live births are born each year suffering from thalassemia. In spite of optimal treatment being available, only a few children can afford it. Unfortunately, most children suffer from complications of blood transfusions, mainly transfusion transmitted viral infections and iron overload. Prevention by carrier detection and prenatal diagnosis is needed in populations with high incidence of the disease, such as Egypt.
The most severe form is the β-thalassemia major, which is characterized by a severe microcytic, hypochromic anemia (Cooley's anemia), whose symptoms appear usually within the first 2 years of life due to iron overload. Chronic iron overload can occur in children with beta-thalassemia as may need blood transfusions throughout their life. Iron overload can lead to growth retardation, pallor, poor appetite, and often jaundice; as well as hinder sexual development during the adolescent period and dysfunction of organs, such as heart, pancreas, and endocrine glands.
When the storage capacity of the body is exceeded, iron remains in free form. The formation of hydroxyl free radicals can be catalyzed by this free iron, leading to damage of cell membranes and protein denaturation. Ultimately, tissue damage occurs which can lead to significant levels of morbidity and mortality. Iron chelation helps prevent complications of iron overload due to repeated blood transfusion. Indeed, the most common complication of beta-thalassemia that leads to death is organ failure, in children taking regular blood transfusions and no appropriate iron chelation. Elevated liver iron concentrations (LICs) and serum ferritin levels can manifest within 1-2 years of starting regular blood transfusions. Children with thalassemia whose serum ferritin level is more than 2500 ng/mL or LIC value is more than 15 mg Fe/kg dry weight are at high risk of development of cardiac diseases such as cardiomyopathy.
Significant advances in treatment modalities and improved clinical management have led to a substantially higher life expectancy of these children. Children with thalassemia major have good survival but little is known about their psychological status. children are less able to voice their concerns and are more vulnerable than adults.
Today, with the help of existing therapies and the use of new drugs to improve iron overload control and timely initiation of treatment, the disease has become a chronic disease and life expectancy in these children has increased. However, repeated blood transfusions and long-term use of iron-chelating drugs affect other aspects of these children' lives and significantly affect their general health, mental health, and quality of life, and their families.
Thalassemia can cause different physiological, emotional, social, financial and behavioral problems that affect the life of both patients and their families, its effects are stronger particularly during school age and adolescence. It can greatly affect the sense of autonomy and mental health. Children with thalassemia major experience a lot of stress throughout their lives which constituted 18.8 %. Successive blood tests for fatigue, fatigue from successive blood transfusions, and subcutaneous injections of iron chelators, in addition to the body, irritate the souls of these patients. So much so that most of these patients also have mental disorders. It was described the fear and anxiety caused by injections in these children as the most difficult aspect of their illness.
Physiological changes occur when a person is threatened with illness, trauma, or stress. The physiological response to the stressor in the cardiovascular system increases blood pressure, changes the number of pulses and respiration, increases oxygen saturation, and increases the risk of arrhythmias. Therefore, it is very important to find an effective solution that is also cost-effective for clinical use.
Stress can be defined as any uncomfortable or agonizing emotional experience associated with changes in behavior as well as biochemical and physiological changes or in simple words we can say it is a feeling of being worried or overwhelmed. It can affect anyone regardless of age or gender of person and result in both physical as well as psychological health issues. Stress among children with thalassemia can be attributed to number of reasons like frequent treatment procedures and hospital visits, decreased life expectancy, expected complications from disease or treatment procedures and the monetary burden on parents. Also, the long painful treatment sessions such as to remove iron as iron overload being a complication of frequent blood transfusions, and an eight hour long painful procedure when injecting chelators by chelation pump is carried out, adding to the stress factors.
Unlike pharmacological treatments, complementary therapies in addition to cost effective, have no serious side effects or drug interactions, they are easy to perform, and well accepted by the patient. It is important to pay attention to additional therapies in the sense that can be performed by nurses without the need for a doctor's prescription, as well as to pave the way for nurses to gain professional independence.
Relaxation is one of the best complementary treatment strategies to decrease stress and mental disorders of the patients in order to improve their physical, psychological, and social functions. Moreover, relaxation increases the secretion of endorphins or analgesic hormone, but reduces the secretion of adrenaline hormone. In the present study, relaxation refers to one of the methods of concentration which is introduced due to its ease of learning and teaching. It was carried out in 4 stages: providing a relaxed environment, being in an appropriate physical position, concentration and creation of an inactive state. Creation of a calm environment, reduce muscle tension and focus by focusing on one word, increasing a person's attention, reducing the number of breaths and lactate in the blood can be occurred in Benson muscle relaxation due to lack of muscle stiffness, number of breaths, pulse and blood pressure are not increased and cardiac output is not increased.
So Benson relaxation therapy, as well as other relaxation techniques, that may cause a decrease in physical and psychological stress, which conceptually can decrease epinephrine, decrease cortisol, decrease glucagon and decrease thyroid hormone. All of these have a positive effect on reducing stress levels. Reduction in stress levels and the attainment of a relaxed condition in patients have positive effect on reducing stress levels. Therefore, various efforts were made to make patients comfortable and remain relaxed.
In addition to the Benson relaxation techniques described above, music therapy is another non-pharmacological methods that is believed to provide a relaxing effect on the patient and it considered to help reduce and even overcome psychological disorders and discomforts such as anxiety, stress, depression, and so on. Music therapy can be defined as the prescribed and organized use of music or its activities to change the maladaptive state in order to help clients achieve therapeutic goals. Music reduces stress by distracting and reducing a person's focus on stressful stimuli. Physicians can use it to reduce stress in children undergoing treatment or those with the possibility of further treatment. Due to the fact that therapeutic music has no side effects, in addition to this, it is easy, cheap, and safe and can be accepted by the client. Numerous studies have examined the effect of music therapy on reducing stress levels and vital signs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –children with thalassemia will receive only routine care of hospital during blood transfusion. |
| Benson's Relaxation Group | Experimental | Behavioral: Benson's Relaxation techniquechildren with thalassemia will receive Benson's relaxation intervention beside routine care of hospital during blood transfusion |
| Music Therapy Group | Experimental | Behavioral: Music therapychildren with thalassemia will receive music therapy intervention beside routine care of hospital during blood transfusion. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preschool stage
Key exclusion criteria (2 listed)
- Free from any neurological disorders.
- Free from major congenital malformations.
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 |
|---|---|---|
| Benson's Relaxation techniqueEach child in the study group had an individual interview with researchers, who demonstrated the Benson relaxation technique while teaching them. The child was then asked to demonstrate it. sit quietly in a comfortable position in separate room., close eyes, deeply relax all muscles, beginning at the feet and progressing up to the face and breathe through nose. Become aware of breathing pattern. As breathes out, say the word one silently to child. For example, breathe in, and then out, say one, in and out, and repeat one. Breathe easily and naturally. It is Continue for 10 minutes and repeated two times. | Behavioural | Benson's Relaxation Group |
| Music therapy* The child lessen to a Mozart's music, which is played before and throughout the blood transfusion procedure. Ambient noise can be reduced by using headphones. As a result, it is easier to see how the intervention has succeeded. * This intervention was done using an MP3 player during the blood transfusion procedure and immediately following the completion of the intervention to prevent the transmission of infections headphones were cleaned with disinfectant after each -use. | Behavioural | Music Therapy Group |
Primary outcome
Tool I: Characteristics of Children with Thalassemia and Their Physiological Parameters Assessment Sheet:
Time frame: children's characteristics will be assessed initially, pre-procedure. physiological parameters of children will be assessed as the following; • "Baseline, pre-blood transfusion procedure" • "During the blood transfusion procedure" • "Immediately after th
This tool was developed by the researcher after reviewing the literature to assess the characteristics of children with thalassemia and their parameters. It includes two parts:Part One: children's characteristics: age, sex, and medical history. level of education, place of residence, Part Two: children's physiological parameters: respiratory rate, heart rate, and O2 saturation.
1 secondary outcome
Tool II: Observational Scale of Behavioral Distress:
Time frame: Children's behavioral reactions to stress will be assessed as the following;• "Baseline, pre-blood transfusion procedure" • "During the blood transfusion procedure" • "Immediately after the blood transfusion procedure"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- BackgroundEl-said S, Darwish A, Abdelrahman D. Stress, anxiety and depression among adolescents suffering from thalassemia. Port Said Scientific Journal of Nursing, 2021;8(3): 149-61. DOI: 10.21608/PSSJN.2021.78945.1112 https://pssjn.journals.ekb.eg/article_212190.html
- Background: PubMed 34633587El-Shanshory MR, Sherief LM, Hassab HM, Ragab SM, Yahia S, Mansour AK, Ahmed AS, Abdou SH, Helmy AM, Watany MM, Gad ALllah AM, Guindy MA, Mourad ZI, Soliman MA, El-Farahaty RM, El-Dahtory F, Darwish A, Elmabood SA, Kabbash IA, Saied SM. Prevalence of iron deficiency anemia and beta thalassemia carriers among relatives of beta thalassemia patients in Nile Delta region, Egypt: a multicenter study. J Egypt Public Health Assoc. 2021 Oct 11;96(1):27. doi: 10.1186/s42506-021-00088-9.
- Background: PubMed 30190750Hisam A, Khan NUS, Tariq NA, Irfan H, Arif B, Noor M. Perceived stress and monetary burden among thalassemia patients and their caregivers. Pak J Med Sci. 2018 Jul-Aug;34(4):901-906. doi: 10.12669/pjms.344.15420.
- BackgroundJajhara I, Choudhary G, Singh J, Chachan V, Kumar A. A study on quality of life among thalassemic children aged 8 to 18 years. Int J Contemp Pediatr 2021; 8: 1667-74. DOI: https://dx.doi.org/10.18203/2349-3291.ijcp20213727.
- BackgroundKaviani M, Bahoosh N, Azima S, Asadi N, Sharif F, Sayadi M. The effect of relaxation on blood sugar and blood pressure changes of women with gestational diabetes: a randomized control trial. Iranian journal of diabetes and obesity, 2014; 6(1): 14-22
- Background: PubMed 32873999Panigrahi M, Swain TR, Jena RK, Panigrahi A, Debta N. Effectiveness of Deferasirox in Pediatric Thalassemia Patients: Experience from a Tertiary Care Hospital of Odisha. Indian J Pharmacol. 2020 May-Jun;52(3):172-178. doi: 10.4103/ijp.IJP_68_18. Epub 2020 Aug 4.
- BackgroundSeifi L, Najafi Ghezeljeh T, Haghani H. The effects of benson relaxation technique and nature sound's on anxiety in patients with heart failure. Nurs Midwifery J. 2017; 15 (2):147-158. http://unmf.umsu.ac.ir/article-1-3036-en.html
- BackgroundSheikhi, A. R., Naderifar, M., Abdullahi M. A, Mastalizadeh, H., Sheikhi, H. R.The Effect of Music Therapy on the Anxiety Level of Children with Thalassemia Major under Blood Transfusion. Arch Pharma Pract 2020; 11(S4):66-9. https://www.researchgate.net/publication/348592642
- BackgroundFoley V. Clinical Measurement. In: Delves -Yates, C. (Ed.) Essentials of Nursing Practice. London: Sage Co., 2015; 349-378.
- Background: PubMed 31879625Packyanathan JS, Lakshmanan R, Jayashri P. Effect of music therapy on anxiety levels on patient undergoing dental extractions. J Family Med Prim Care. 2019 Dec 10;8(12):3854-3860. doi: 10.4103/jfmpc.jfmpc_789_19. eCollection 2019 Dec.
- BackgroundPoorolajal J. Effect of Benson relaxation technique on the preoperative anxiety and hemodynamic status: A single blind randomized clinical trial, 2017; 17 (1): 33 - 38
- BackgroundAbd Elgwad F. Relaxation Therapy, Preeclampsia Effect of Benson's Relaxation Therapy on Stress and Physiological Parameters among Women with Preeclampsia. ASNJ, 2021;.23 (1) :63-74.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benson's Relaxation technique and Music therapy in people with Thalassemia in Children, run by Alexandria University at 1 site in Egypt.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tool I: Characteristics of Children with Thalassemia and Their Physiological Parameters Assessment Sheet: (time frame: children's characteristics will be assessed initially, pre-procedure. physiological parameters of children will be assessed as the following; • "Baseline, pre-blood transfusion procedure" • "During the blood transfusion procedure" • "Immediately after th). 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 NCT05730374, which also lists 25 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 20 Jul 2023.