Nonpharmacological Approaches and Parental Education in Children With Sickle Cell Disease

Nursing Caries Clinical Trial

Official title:

Nonpharmacological Approaches Used by Parents of Children With Sickle Cell Disease and the Effectiveness of Education Given to Nonpharmacological Approaches

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121247
• Other study ID #: AkdenizUnursingfaculty
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: February 2, 2016

Study information

• Verified date: October 2019
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: Sickle cell disease (SCD) is a hereditary disease. Approximately 5% of the world's population carries trait genes for haemoglobin disorders, mainly, sickle-cell disease and thalassaemia. The incidence of sickle cell disease varies according to different geographical locations. Persons with SCD experience both acute and chronic pain. it is important that nonpharmacological therapies be investigated and used as complements to pharmacological therapies to address and treat both acute and chronic pain for those with SCD. An educational program involving parents with children with SCD can help parents use nonpharmacological methods for their children in reducing pain. The training program allows parents to develop their knowledge of the SCD and the importance of non-pharmacological methods, and may provide parents with the opportunity to develop preventive attitudes towards reducing pain crises. The research has two purposes. The first is to identify the non-pharmacological approaches that parents use to help their children with sickle cell disease in Turkey, Chad. Second, to determine the effectiveness of non-pharmacological approaches given to parents in Turkey, Chad.

Method: This study is an experimental research method using a quasi‐experimental design. This study used a pretest and posttest, with a design that is used is the two group pretest-posttest design. The study was conducted on the parents of children with sickle cell disease diagnosed and followed up in the Pediatric Hematology Oncology polyclinics of two hospitals in Chad in Central Africa between September 2015 and February 2016. The study found in April 2016 and July 2016 between Turkey's southern Antalya and Mersin two university hospital outpatient Children's pediatric hematology oncology has made clinic on sickle cell disease diagnosed and monitored the children's parents. The parents were selected using eligibility criteria and the study was performed in three steps (Pre-intervention testing session, education session, and post-intervention testing session). In the first step, "Information Form", "Parents' Experience of Nonpharmacological Methods Questionnaire", and "Nonpharmacological Approaches Used by Parents for Their Children and Knowledge of Parents about Nonpharmacological Approaches Questionnaire" questionnaires were applied to parents. In the second step an individual education was conducted by the researcher using the education book. In the third step, the questionnaire were reapplied after 3 weeks.

Description:

In this study, nonpharmacological approaches used by parents of sickle cell anemia patients were determined. However, the effectiveness of the education given to non-pharmacological approaches to parents was examined.

The study was first applied to parents in Chad. Then applied to parents in Turkey. n the study, parents' experience of nonpharmacological approaches questionnaire was used.

The form consisted of 8 multiple-choice questions, including a single open-ended question. If the parent used a nonpharmacological approach for the child, the name of the nonpharmacological approach (open ‐ ended question) was written on the form.

In addition, the form was asked to write the frequency of using a nonpharmacological approach (sometimes / always / not use). Parents' pre- and post-educational knowledge of non-pharmacological methods to reduce the pain of children with SCD was measured with a closed-ended questionnaire developed by the researchers in the literature (he knows/he does not know). Nonpharmacological approaches in sickle cell disease training book was the intervention of this study. Nonpharmacological approaches in sickle cell disease training book "Parental Education Program for Nonpharmacological Approaches Used in Pain in Children with Sickle Cell Disease", was prepared according to previous studies by the researchers. The language used for administration of the instruments and the language used in education book was French / Arabic / Turkish.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: February 2, 2016
• Est. primary completion date: February 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Turkish is spoken by parents and in Chad, parents can speak either Arabic or French

• that at least one member of the family knows how to either read or write

• parents agreeing to face-to-face interviewing

Exclusion Criteria:

• the participant to come out of his own accord

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Nursing Caries

Intervention

Other:
• nonpharmacological approaches to parents of children with sickle cell disease training program
use of non-pharmacological approaches in children with sickle cell disease, parent education

Locations

Country	Name	City	State
Turkey	Emine EFE	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Crosby LE, Simmons K, Kaiser P, Davis B, Boyd P, Eichhorn T, Mahaney T, Joffe N, Morgan D, Schibler K, Anderson V, Quinn CT, Kalinyak KA. Using Quality Improvement Methods to Implement an Electronic Medical Record (EMR) Supported Individualized Home Pain Management Plan for Children with Sickle Cell Disease. J Clin Outcomes Manag. 2014 May;21(5):210-217. — View Citation

Dampier C, Ely B, Brodecki D, Coleman C, Aertker L, Sendecki JA, Leiby B, Kesler K, Hyslop T, Stuart M. Pain characteristics and age-related pain trajectories in infants and young children with sickle cell disease. Pediatr Blood Cancer. 2014 Feb;61(2):291-6. doi: 10.1002/pbc.24796. Epub 2013 Sep 24. — View Citation

Majumdar S, Thompson W, Ahmad N, Gordon C, Addison C. The use and effectiveness of complementary and alternative medicine for pain in sickle cell anemia. Complement Ther Clin Pract. 2013 Nov;19(4):184-7. doi: 10.1016/j.ctcp.2013.05.003. Epub 2013 Jun 22. — View Citation

Makani J, Williams TN, Marsh K. Sickle cell disease in Africa: burden and research priorities. Ann Trop Med Parasitol. 2007 Jan;101(1):3-14. Review. — View Citation

Matthie N, Jenerette C. Understanding the Self-Management Practices of Young Adults with Sickle Cell Disease. J Sick Cell Dis Hemoglobinopathies. 2017 May;2017:76-87. — View Citation

Ratanawongsa N, Haywood C Jr, Bediako SM, Lattimer L, Lanzkron S, Hill PM, Powe NR, Beach MC. Health care provider attitudes toward patients with acute vaso-occlusive crisis due to sickle cell disease: development of a scale. Patient Educ Couns. 2009 Aug;76(2):272-8. doi: 10.1016/j.pec.2009.01.007. Epub 2009 Feb 23. — View Citation

Thompson WE, Eriator I. Pain control in sickle cell disease patients: use of complementary and alternative medicine. Pain Med. 2014 Feb;15(2):241-6. doi: 10.1111/pme.12292. — View Citation

Williams H, Tanabe P. Sickle Cell Disease: A Review of Nonpharmacological Approaches for Pain. J Pain Symptom Manage. 2016 Feb;51(2):163-77. doi: 10.1016/j.jpainsymman.2015.10.017. Epub 2015 Nov 17. Review. — View Citation

Wilson BH, Nelson J. Sickle cell disease pain management in adolescents: a literature review. Pain Manag Nurs. 2015 Apr;16(2):146-51. doi: 10.1016/j.pmn.2014.05.015. Epub 2014 Aug 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Information form	The information questionnaire contains information about parents and children. Parents; age, parents participating in the survey, education, occupation, marital status. Children; age, sex, number of siblings diagnosed with SCD, frequency of the child's pain crisis, medicines or drugs used by the child.	In one week
Primary	Parents' experience of nonpharmacological approaches questionnaire	The form consisted of 8 multiple-choice questions, including the experience of parents using nonpharmacological approaches on SCD pain in their children, and asked for the name of the method using a single open-ended question. If the parent used nonpharmacological approach for the child, the name of the nonpharmacological approach (open-ended question) was written on the form.; In addition, the form was asked to write the frequency of using nonpharmacological approach (sometimes/always/not use). The questionnaire about the nonpharmacological approach used by the parents was created by the researchers. This form, prepared by the researcher according to the literature, includes nonpharmacological approaches that parents can use in pain crisis.	In one week
Primary	Nonpharmacological approaches of pain relief parental information questionnaire	Parents' pre- and post-educational knowledge of non-pharmacological methods to reduce the pain of children with SCD was measured with a closed-ended questionnaire developed by the researchers in the literature (he knows/he does not know).; Nonpharmacological approaches of pain relief parental information questionnaire was prepared according to previous studies by the researchers (Williams&Tanabe, 2016; Wong, 2013; Demir, 2012; Monti&Yang, 2005; Delicou & Maragkos, 2013).; Five expert opinions were consulted for the understandability of the questionnaire before the study. Two of them were doctors specializing in Sickle Cell Disease and three of them were the lecturers of the nursing department.	In three weeks