Nonpharmacological Approaches and Parental Education in Children With Sickle Cell Disease

NCT ID: NCT04121247

Last Updated: 2019-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2016-02-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nursing Caries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

the type of initiative tests to determine the effectiveness of education provided to parents in both countries.

However, it tests the non-pharmacological approaches used by parents between the two countries.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers
parents and care provider

Study Groups

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Experimental: Parents in Chad will be trained

The education was given individually by the researcher (first researcher / author), before examining the child's doctor. The interactive education was completed in 30-40 min, using questions-answers. The education was conducted by the researcher using the education book.

Group Type EXPERIMENTAL

nonpharmacological approaches to parents of children with sickle cell disease training program

Intervention Type OTHER

use of non-pharmacological approaches in children with sickle cell disease, parent education

Experimental: Parents in Turkey will be trained

The education was given individually by the researcher (first researcher / author), before examining the child's doctor. The interactive education was completed in 30-40 min, using questions-answers. The education was conducted by the researcher using the education book.

Group Type EXPERIMENTAL

nonpharmacological approaches to parents of children with sickle cell disease training program

Intervention Type OTHER

use of non-pharmacological approaches in children with sickle cell disease, parent education

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Emine EFE

Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emine EFE

Role: STUDY_DIRECTOR

Akdeniz University

Locations

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Emine EFE

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 25258504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24115743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24199970 (View on PubMed)

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. doi: 10.1179/136485907X154638.

Reference Type BACKGROUND
PMID: 17244405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26596876 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24524842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25175555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30505880 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19233587 (View on PubMed)

Other Identifiers

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AkdenizUnursingfaculty

Identifier Type: -

Identifier Source: org_study_id

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