Nonpharmacological Approaches and Parental Education in Children With Sickle Cell Disease

October 15, 2019 updated by: Prof. Dr. Emine EFE, Akdeniz University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07058
        • Emine EFE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Information form
Time Frame: In one week
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
Parents' experience of nonpharmacological approaches questionnaire
Time Frame: In one week

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
Nonpharmacological approaches of pain relief parental information questionnaire
Time Frame: In three weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Investigators

  • Study Director: Emine EFE, Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 2, 2016

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (Actual)

October 9, 2019

Study Record Updates

Last Update Posted (Actual)

October 16, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AkdenizUnursingfaculty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data sharing plans for the current study are unknown and will be made available at a later date

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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