Benson's Relaxation Technique, Music Therapy for Children With Thalassemia

NCT05730374 | Completed

• 1 other identifier: BRT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thalassemia in Children

Keywords

Benson's Relaxation; Music Therapy; Stress; Thalassemia

Outcome Measures

Primary Outcomes (1)

• 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.

  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:

  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"

Study Arms (3)

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

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.

Behavioral: Music therapy

Interventions

Benson's Relaxation technique BEHAVIORAL

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.

Benson's Relaxation Group

Music therapy BEHAVIORAL

* 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.

Music Therapy Group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• preschool stage

You may not qualify if:

• Free from any neurological disorders.
• Free from major congenital malformations.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

the Hematology Out-Patient Clinic of the Children's University Hospital at El-Shatby

Alexandria, Egypt

Location

Related Publications (25)

• 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

  BACKGROUND

• 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.

  PMID: 34633587 BACKGROUND

• Hisam 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.

  PMID: 30190750 BACKGROUND

• Jajhara 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 32873999 BACKGROUND

• Seifi 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

  BACKGROUND

• 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

  BACKGROUND

• Foley V. Clinical Measurement. In: Delves -Yates, C. (Ed.) Essentials of Nursing Practice. London: Sage Co., 2015; 349-378.

  BACKGROUND

• 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.

  PMID: 31879625 BACKGROUND

• Poorolajal J. Effect of Benson relaxation technique on the preoperative anxiety and hemodynamic status: A single blind randomized clinical trial, 2017; 17 (1): 33 - 38

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28619305 BACKGROUND

• Salkhordeh H, Sabet B, mahboobi M, Babajani S. The Effect of Music Therapy on Preoperational Anxiety and Pain in Waiting Room. Paramedical Sciences and Military Health. 2017; 12 (2) :55-62

  BACKGROUND

• Najafi S S. The Effect of Music Therapy on the Level of Anxiety and vital Signs in Patients undergoing trans-esophageal Echocardiography . JAP. 2018; 9 (1) :1-11

  BACKGROUND

• Ghanbari N, The Effect of Music Therapy on Pain and Anxiety of Children Diagnosed with Leukemia during P 19271 - 19286 Received 25 April 2021; Accepted 08 May 2021. 19271 http://annalsofrscb.ro

  BACKGROUND

• Daneshpajooh L, Najafi Ghezeljeh T, Haghani H. Comparison of the effects of inhalation aromatherapy using Damask Rose aroma and the Benson relaxation technique in burn patients: A randomized clinical trial. Burns. 2019 Aug;45(5):1205-1214. doi: 10.1016/j.burns.2019.03.001. Epub 2019 Apr 2.

  PMID: 30948278 BACKGROUND

• Kurniasari AN, Kustanti A, Harmilah H. The effect Benson relaxation technique with anxiety in hemodialysis patients in Yogyakarta. Indonesian J Nurs Pract 2016;1:40-7.

  BACKGROUND

• Mosher CE, Jaynes HA, Hanna N, Ostroff JS. Distressed family caregivers of lung cancer patients: an examination of psychosocial and practical challenges. Support Care Cancer. 2013 Feb;21(2):431-7. doi: 10.1007/s00520-012-1532-6. Epub 2012 Jul 14.

  PMID: 22797839 BACKGROUND

• Abarghoee SN, Mardani A, Baha R, Aghdam NF, Khajeh M, Eskandari F, Vaismoradi M. Effects of Benson Relaxation Technique and Music Therapy on the Anxiety of Primiparous Women Prior to Cesarean Section: A Randomized Controlled Trial. Anesthesiol Res Pract. 2022 Dec 23;2022:9986587. doi: 10.1155/2022/9986587. eCollection 2022.

  PMID: 36589598 BACKGROUND

• Buckley SJ. Executive Summary of Hormonal Physiology of Childbearing: Evidence and Implications for Women, Babies, and Maternity Care. J Perinat Educ. 2015;24(3):145-53. doi: 10.1891/1058-1243.24.3.145.

  PMID: 26834435 BACKGROUND

• Najafighazaljeh S. Comparison of Benson's Muscle Relaxation and Voice of Nature on Anxiety in Patients with Heart Failure: A Randomized Clinical Trial with Control Group. Urmia Nur and Mid J, 2017;15(2): 147

  BACKGROUND

• Cahyat Y, Rosdiana I, Elengoe A, Podder S. Effect of Benson Relaxation and Aromatherapy on Blood Glucose Levels in Patients With Type II Diabetes Mellitus. Mal J Med Health Sci 2020; 16(10): 43-49, https://www.researchgate.net/publication/349289409_Effect_of_Benson_Relaxation_and_Aromatherapy_on_Blood_Glucose_Levels_in_Patients_With_Type_II_Diabetes_Mellitus

  BACKGROUND

MeSH Terms

Conditions

Thalassemia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 15, 2023
• Study Start: August 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: April 30, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)