Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nonpharmacological Approaches and Parental Education in Children With Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04121247
Recruitment Status : Completed
First Posted : October 9, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Emine EFE, Akdeniz University

Brief 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.


Condition or disease Intervention/treatment Phase
Nursing Caries Other: nonpharmacological approaches to parents of children with sickle cell disease training program Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Double (Participant, Care Provider)
Masking Description: parents and care provider
Primary Purpose: Supportive Care
Official Title: Nonpharmacological Approaches Used by Parents of Children With Sickle Cell Disease and the Effectiveness of Education Given to Nonpharmacological Approaches
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : February 1, 2016
Actual Study Completion Date : February 2, 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121247


Locations
Layout table for location information
Turkey
Emine EFE
Antalya, Turkey, 07058
Sponsors and Collaborators
Akdeniz University
Investigators
Layout table for investigator information
Study Director: Emine EFE Akdeniz University

Publications:

Layout table for additonal information
Responsible Party: Prof. Dr. Emine EFE, Prof.Dr., Akdeniz University
ClinicalTrials.gov Identifier: NCT04121247    
Other Study ID Numbers: AkdenizUnursingfaculty
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data sharing plans for the current study are unknown and will be made available at a later date

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Emine EFE, Akdeniz University:
sickle cell disease
nonpharmacological approaches
pain
parent
nurse
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn