Sexual HealthNCT05732012
The Effectiveness of the Sexual Health Psychoeducation Program for Physically Disabled Adolescents
A study testing Sexual Health Psychoeducation Program in people with Sexual Health and Adolescent, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This research was planned to evaluate the effectiveness of the online psychoeducation program including sexual health education in physically disabled adolescents. Materials and Methods: In this study, a randomized experimental design with pretest-posttest, follow-up measurement, intervention and control… Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Health, Adolescent, Physically Disabled
- What is being tested?
- Sexual Health Psychoeducation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Apr 2021to 14 Oct 2021
- 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 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- To be between the ages of 12-15
- Volunteering to participate in the research
- Not having a situation that prevents verbal communication
- Having and participating in online communication tools (computer, tablet, phone…)
Who cannot join
- -Individuals with intellectual disabilities who have difficulty understanding and answering the research questions clearly and accurately. Not having online communication tools and not knowing how to participate (computer, tablet, phone…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Online Sexual Health Psychoeducation Program Given to Physically Disabled Adolescents on Sexual Health Attitudes
Objective: This research was planned to evaluate the effectiveness of the online psychoeducation program including sexual health education in physically disabled adolescents.
Materials and Methods: In this study, a randomized experimental design with pretest-posttest, follow-up measurement, intervention and control groups was used to evaluate the effectiveness of the sexual health online psychoeducation program in adolescents with physical disabilities. The universe of the study consists of adolescent members aged 12-15 in the Turkish Spinal Cord Paralysis Association.(N :600). Nearly 90 people with physical disabilities and their families, who were included in the inclusion criteria of the study, were reached through the institution. 62 people were included in the study as a result of the foresights made due to the intensity of their online classes due to the Covid- 19 pandemic, and their inability to volunteer for the subject of the research (they are ashamed and do not want to discuss it as a topic to be discussed). . Participants were divided into 31 participants as intervention group and 31 participants as control group by randomization method. The intervention group was divided into 3 groups of 10 and a six-week psychoeducation program lasting 60 minutes once a week was applied. At the end of the training, the intervention and control groups were given a post-test and a follow-up test at the end of the 3rd month.
Read the detailed description
In addition to the nature of the adolescence period, which causes both physical and sexual differences and includes various difficulties, this period can be more complex for disabled adolescents. In addition to their physical problems, these adolescents try to make sense of their changing bodies and sexual identities, and according to studies, disabled adolescents may experience more psychosocial and psychosexual problems than adolescents without disabilities. Adolescents are expected to form sexual attitudes, values and engage in healthy sexual behaviors, as well as adapting to the functions of their changing and sexually maturing body. . Although sexual health education should have started within the family, families think that their adolescent children are not yet grown up and do not have a sexual life. In addition, it has been observed that the priority of families for their children is physical discomfort, and such developmental problems can be put in the background. This situation causes physically disabled adolescents to spend this process alone and cannot access sufficient information.
Psychoeducation applied in this study; meeting the sexual health education needs of the physically disabled; It is an online psychoeducation program designed to develop a positive attitude towards sexual health, increase adaptation to physical and emotional changes that may occur during adolescence, as well as the need for information. It is thought that the study can serve as a model for sexual health programs in adolescents with physical disabilities. This research was conducted to evaluate the effectiveness of the online psychoeducation program, which includes sexual health education, on sexual knowledge and attitudes in physically disabled adolescents.
The hypotheses of this study are:
H1. There is a significant difference between the post-test and follow-up total scores of the intervention group physically disabled adolescents compared to the pre-test total scores. It is expected that the control group scores will not differ.
H2. There is a significant difference between the post-test and follow-up test scores of the physically disabled adolescents in the intervention group and the post-test and follow-up test scores of the physically disabled adolescents in the control group in favor of the intervention group.
- Conditions
- Sexual Health, Adolescent, Physically Disabled, Psychological, Education
- Being tested
- Sexual Health Psychoeducation Program
- Keywords
- Adolescent, Sexual health, Psychoeducation, Physically disabled, Sexuality
- Medical subject headings
- Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual Health Psychoeducation ProgramBehavioural
62 adolescents were included in the study. Adolescents were assigned to intervention and control groups by randomization using simple numbers table. The intervention group was divided into 3 groups of 10 and included in a six-week psychoeducation program that lasted for one hour once a week, and 55 adolescents completed the program. The data on the sociodemographic characteristics of the adolescents constituting the sample were collected with the "Participant Information Form". Data on the effectiveness of the psychoeducation program on sexual health knowledge and attitudes were collected with the "Sexual Health Knowledge and Attitude Inventory" before the psychoeducation, at the end of the training and at the 3rd month of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Group-1 | Experimental | Interventions applied on Group-1 participants. Receives: Behavioral: Sexual Health Psychoeducation Program |
| Group-2 | No intervention | No interventions applied on Group-2 participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentiation of Attitude Scores Regarding Sexually Transmitted Diseases by Groups
Measured: 4 month
Differentiation of Attitude Scores Regarding Sexuality According to Groups
Measured: 4 month
Differentiation of Attitude Scores Regarding Sexual Behaviors by Groups
Measured: 4 month
Differences in Attitude Scores Regarding Sexual Health and Personal Hygiene by Groups
Measured: 4 month
Differentiation of Attitude Scores Regarding Gender Roles by Group
Measured: 4 month
Differentiation of Attitude Scores Regarding Sexual Abuse by Groups
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start7 Apr 2021
- Primary completion16 Jul 2021
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sexual HealthStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Spinal Cord Paralysis Association
- Responsible party
- Principal investigator, Raife Aşık, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732012
- Sponsor's protocol ID
- Sexual Health Psychoeducation
- Status last verified
- Feb 2023
- First submitted
- 21 Jan 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huurre T, Aro H.The psychosocial well-being of Finnish adolescents with visual impairments versus those with chronic conditions and those with no disabilities. Journal of Visual Impairment and Blindness.2000;94:625-637.
Karaca S, Özaltın G. Experience with Structural Group Process: What Does a Group Process Executed with Blind Adolescents Teach?. Journal of Psychiatric Nursing. 2010; 1(2): 77-85.
Greydanus DE, Pratt HD, Patel DR. Concepts of contraception for adolescent and young adult women with chronic illness and disability. Dis Mon. 2012 May;58(5):258-320. doi: 10.1016/j.disamonth.2012.02.001.
PubMed 22510362
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Online Sexual Health Psychoeducation Program Given to Physically Disabled Adolescents on Sexual Health Attitudes
- ClinicalTrials.gov ID
- NCT05732012
- Acronym / sponsor ID
- Sexual Health Psychoeducation
- Conditions
- Sexual Health, Adolescent, Physically Disabled, Psychological, Education
- Keywords
- Adolescent, Sexual health, Psychoeducation, Physically disabled, Sexuality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- Turkish Spinal Cord Paralysis Association
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 16 Feb 2023 (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.
Objective: This research was planned to evaluate the effectiveness of the online psychoeducation program including sexual health education in physically disabled adolescents.
Materials and Methods: In this study, a randomized experimental design with pretest-posttest, follow-up measurement, intervention and control groups was used to evaluate the effectiveness of the sexual health online psychoeducation program in adolescents with physical disabilities. The universe of the study consists of adolescent members aged 12-15 in the Turkish Spinal Cord Paralysis Association.(N :600). Nearly 90 people with physical disabilities and their families, who were included in the inclusion criteria of the study, were reached through the institution. 62 people were included in the study as a result of the foresights made due to the intensity of their online classes due to the Covid- 19 pandemic, and their inability to volunteer for the subject of the research (they are ashamed and do not want to discuss it as a topic to be discussed). . Participants were divided into 31 participants as intervention group and 31 participants as control group by randomization method. The intervention group was divided into 3 groups of 10 and a six-week psychoeducation program lasting 60 minutes once a week was applied. At the end of the training, the intervention and control groups were given a post-test and a follow-up test at the end of the 3rd month.
Detailed description
In addition to the nature of the adolescence period, which causes both physical and sexual differences and includes various difficulties, this period can be more complex for disabled adolescents. In addition to their physical problems, these adolescents try to make sense of their changing bodies and sexual identities, and according to studies, disabled adolescents may experience more psychosocial and psychosexual problems than adolescents without disabilities. Adolescents are expected to form sexual attitudes, values and engage in healthy sexual behaviors, as well as adapting to the functions of their changing and sexually maturing body. . Although sexual health education should have started within the family, families think that their adolescent children are not yet grown up and do not have a sexual life. In addition, it has been observed that the priority of families for their children is physical discomfort, and such developmental problems can be put in the background. This situation causes physically disabled adolescents to spend this process alone and cannot access sufficient information.
Psychoeducation applied in this study; meeting the sexual health education needs of the physically disabled; It is an online psychoeducation program designed to develop a positive attitude towards sexual health, increase adaptation to physical and emotional changes that may occur during adolescence, as well as the need for information. It is thought that the study can serve as a model for sexual health programs in adolescents with physical disabilities. This research was conducted to evaluate the effectiveness of the online psychoeducation program, which includes sexual health education, on sexual knowledge and attitudes in physically disabled adolescents.
The hypotheses of this study are:
H1. There is a significant difference between the post-test and follow-up total scores of the intervention group physically disabled adolescents compared to the pre-test total scores. It is expected that the control group scores will not differ.
H2. There is a significant difference between the post-test and follow-up test scores of the physically disabled adolescents in the intervention group and the post-test and follow-up test scores of the physically disabled adolescents in the control group in favor of the intervention group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-1 | Experimental | Behavioral: Sexual Health Psychoeducation ProgramInterventions applied on Group-1 participants. |
| Group-2 | No intervention | –No interventions applied on Group-2 participants. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- To be between the ages of 12-15
- Volunteering to participate in the research
- Not having a situation that prevents verbal communication
- Having and participating in online communication tools (computer, tablet, phone…)
Key exclusion criteria (1 listed)
- -Individuals with intellectual disabilities who have difficulty understanding and answering the research questions clearly and accurately. Not having online communication tools and not knowing how to participate (computer, tablet, phone…)
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 |
|---|---|---|
| Sexual Health Psychoeducation Program62 adolescents were included in the study. Adolescents were assigned to intervention and control groups by randomization using simple numbers table. The intervention group was divided into 3 groups of 10 and included in a six-week psychoeducation program that lasted for one hour once a week, and 55 adolescents completed the program. The data on the sociodemographic characteristics of the adolescents constituting the sample were collected with the "Participant Information Form". Data on the effectiveness of the psychoeducation program on sexual health knowledge and attitudes were collected with the "Sexual Health Knowledge and Attitude Inventory" before the psychoeducation, at the end of the training and at the 3rd month of follow-up. | Behavioural | Group-1 |
Primary outcome
Differentiation of Attitude Scores Regarding Sexually Transmitted Diseases by Groups
Time frame: 4 month
Differentiation of Attitude Scores Regarding Sexuality According to Groups
Time frame: 4 month
Differentiation of Attitude Scores Regarding Sexual Behaviors by Groups
Time frame: 4 month
Differences in Attitude Scores Regarding Sexual Health and Personal Hygiene by Groups
Time frame: 4 month
Differentiation of Attitude Scores Regarding Gender Roles by Group
Time frame: 4 month
Differentiation of Attitude Scores Regarding Sexual Abuse by Groups
Time frame: 4 month
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 Feb 2023.
- BackgroundHuurre T, Aro H.The psychosocial well-being of Finnish adolescents with visual impairments versus those with chronic conditions and those with no disabilities. Journal of Visual Impairment and Blindness.2000;94:625-637.
- BackgroundKaraca S, Özaltın G. Experience with Structural Group Process: What Does a Group Process Executed with Blind Adolescents Teach?. Journal of Psychiatric Nursing. 2010; 1(2): 77-85.
- Background: PubMed 22510362Greydanus DE, Pratt HD, Patel DR. Concepts of contraception for adolescent and young adult women with chronic illness and disability. Dis Mon. 2012 May;58(5):258-320. doi: 10.1016/j.disamonth.2012.02.001.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual Health Psychoeducation Program in people with Sexual Health and Adolescent, run by Marmara 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 4 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 Feb 2023. 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?
Differentiation of Attitude Scores Regarding Sexually Transmitted Diseases by Groups (time frame: 4 month). The study lists 6 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 NCT05732012, which also lists 3 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 Feb 2023.