Nursing CariesNCT04121247
Nonpharmacological Approaches and Parental Education in Children With Sickle Cell Disease
A study testing nonpharmacological approaches to parents of children with sickle cell disease training program in people with Nursing Caries, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries
- What is being tested?
- nonpharmacological approaches to parents of children with sickle cell disease training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2015to 2 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- the participant to come out of his own accord
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nursing Caries
- Being tested
- nonpharmacological approaches to parents of children with sickle cell disease training program
- Keywords
- sickle cell disease, nonpharmacological approaches, pain, parent, nurse
- Medical subject headings
- Anemia, Sickle Cell, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonpharmacological approaches to parents of children with sickle cell disease training programOther
use of non-pharmacological approaches in children with sickle cell disease, parent education
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Parents in Chad will be trained | Experimental | 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. Receives: Other: nonpharmacological approaches to parents of children with sickle cell disease training program |
| Experimental: Parents in Turkey will be trained | Experimental | 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. Receives: Other: nonpharmacological approaches to parents of children with sickle cell disease training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: In one week
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.
Measured: In one week
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.
Measured: In three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Sep 2015
- Primary completion1 Feb 2016
- Study completion2 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Emine EFE, Akdeniz University
- Investigators
- Emine EFE, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121247
- Sponsor's protocol ID
- AkdenizUnursingfaculty
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data sharing plans for the current study are unknown and will be made available at a later date
Publications
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.
PubMed 25258504Dampier 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.
PubMed 24115743Majumdar 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.
PubMed 24199970Makani 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.
PubMed 17244405Williams 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.
PubMed 26596876Thompson 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.
PubMed 24524842Wilson 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.
PubMed 25175555Matthie 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.
PubMed 30505880Ratanawongsa 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.
PubMed 19233587
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonpharmacological Approaches Used by Parents of Children With Sickle Cell Disease and the Effectiveness of Education Given to Nonpharmacological Approaches
- ClinicalTrials.gov ID
- NCT04121247
- Acronym / sponsor ID
- AkdenizUnursingfaculty
- Conditions
- Nursing Caries
- Keywords
- sickle cell disease, nonpharmacological approaches, pain, parent, nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 2 Feb 2016 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Parents in Chad will be trained | Experimental | Other: nonpharmacological approaches to parents of children with sickle cell disease training programThe 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. |
| Experimental: Parents in Turkey will be trained | Experimental | Other: nonpharmacological approaches to parents of children with sickle cell disease training programThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- the participant to come out of his own accord
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nonpharmacological approaches to parents of children with sickle cell disease training programuse of non-pharmacological approaches in children with sickle cell disease, parent education | Other | Experimental: Parents in Chad will be trained, Experimental: Parents in Turkey will be trained |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Background: PubMed 25258504Crosby 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.
- Background: PubMed 24115743Dampier 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.
- Background: PubMed 24199970Majumdar 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.
- Background: PubMed 17244405Makani 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.
- Background: PubMed 26596876Williams 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.
- Background: PubMed 24524842Thompson 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.
- Background: PubMed 25175555Wilson 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.
- Background: PubMed 30505880Matthie 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.
- Background: PubMed 19233587Ratanawongsa 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.
- Individual participant dataSharing planned: No. The data sharing plans for the current study are unknown and will be made available at a later date
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine EFE study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nonpharmacological approaches to parents of children with sickle cell disease training program in people with Nursing Caries, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information form (time frame: In one week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04121247, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.