Efficacy of working with parents to reduce punishment frequency of children with enuresis
| ISRCTN | ISRCTN46655645 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46655645 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/06/2013
- Registration date
- 12/07/2013
- Last edited
- 15/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Enuresis (bedwetting) can cause innumerable problems for the child and his parents and affects about 10% of the seven-year-old children. The lack of understanding of the parents about their childrens bedwetting has punishment as one of the results. The aim of this study is to find out the how good the psychological method given to the parents during the treatment of the child with bedwetting is. Along with this we aim to define the profile of the family of such children, to identify the perception of family support and to describe the frequency of punishment practiced by the parents in the study group compared with the control group.
Who can participate?
60 bedwetting children aged between 6 and 18 years can participate in this study.
What does the study involve?
Participants will be randomly allocated to one of two groups: study group and the control group. Parents in the study group will receive psychological counselling and children will receive treatment in an environment that has toys and playful materials. Parents and children belonging to the control group receive treatment as usual.
What are the possible benefits and risks of participating?
There may be improvement in bedwetting, reduction in punishment frequency and improvement in behaviour problems.There are no risks of participating in the study and all children who are not included in the study, received other types of treatment, offered to all children who seek care in the outpatient uropediatria HU-CAS/UFJF.
Where is the study run from?
The University Hospital of the Federal University of Juiz de Fora (Hospital Universitário da Universidade Federal de Juiz De For a), Brazil.
When is the study starting and how long is it expected to run for?
The study will start in December 2015 and will run for one year.
Who is funding the study?
The study is funded by the investigator.
Who is the main contact?
Mr Cacilda Andrade de Sá
cacildaandrade04@yahoo.com.br
Contact information
Scientific
Rua: Coronel Severiano de Resende, 191, centro.
Santos Dumont
36240000
Brazil
| Phone | 3288292111 |
|---|---|
| cacildaandrade04@yahoo.com.br |
Study information
| Study design | Randomized blinded interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy of working with parents to reduce punishment frequency of children with enuresis: a randomized, blinded trial |
| Study objectives | Punishment reduction in children, with monosymptomatic enuresis, who presented to psychological service with their family, compared with the control group, where the family did not receive the service. |
| Ethics approval(s) | Committee on Ethics in Human Research - UFJF (CEP-UFJF): 075-420-2011 FR:432875 CAAF:0050.0.420.000-11 |
| Health condition(s) or problem(s) studied | Enuresis |
| Intervention | The participants are randomised to two groups: 1. Intervention group: The parent psychological appointment will be conducted by the researcher, in a place and time different from the child's. It will take 30 minutes in a private room, every 15 days. After 6 months of treatment, the parent will have an appointment every 30 days for a period of 6 months. The child will be seen separately from his/her parent, in separate place and time. The appointment will last 30 minutes, every 15 days, and a playful material will be used to facilitate the childs care. After 6 months the children will be seen once every month for a period of 6 months. 2. Control Group: Children receive the care without psychological support to parents. After 6 months the children will be seen once every month for a period of 6 months. Clinical outcome data will be recorded for further evaluations. Those who need follow-up assistance, after the survey period, will be forwarded to the psychology service. Follow Up Length: 6 month(s); Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure | The results, that will be evaluated, after six months of intervention, are enuresis improvement (Nocturnal Diary), punishment frequency reduction, improvement in behavior problems, and evasion decrease. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/12/2015 |
| Completion date | 01/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 66 |
| Key inclusion criteria | Patients between 6 and 19 years old who are attending the enuresis clinic and with monosymptomatic enuresis |
| Key exclusion criteria | 1. Those unwilling to participate in the research, or has difficulty in understanding the goals of it. 2. Patients with psychiatric, renal, neurological disorders, non-monosymptomatic enuresis 3. Those who are already undergoing other treatment for enuresis in the last six months |
| Date of first enrolment | 01/12/2015 |
| Date of final enrolment | 01/12/2016 |
Locations
Countries of recruitment
- Brazil
Study participating centre
36240000
Brazil
Sponsor information
University/education
Av. Eugênio do Nascimento s/no
Bairro Dom Bosco
Faculdade de Medicina
2o andar (ao lado do HU/CAS)
Juiz de Fora MG
CEP 36038-330
Brazil
| Phone | 55 (32) 2102 -3848 |
|---|---|
| ppgs.medicina@ufjf.edu.br | |
"ROR" |
https://ror.org/04yqw9c44 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2021 | 15/09/2020 | Yes | No |
Editorial Notes
15/09/2020: Publication reference and total final enrolment number added.
