Main Heading (Descriptor) TermsNCT06508905
Sleep Buddy Application in Hospitalized Children
A study testing Sleep buddy in people with Main Heading (Descriptor) Terms, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study was planned as a randomized controlled experimental study to investigate the effect of sleep companion application on psychosocial symptoms in hospitalized school children aged 6-12 years. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Main Heading (Descriptor) Terms
- What is being tested?
- Sleep buddy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 30 Sep 2024
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalized school-age children (6-12 years old),
- No mental disability,
- Volunteer to participate in the research,
- No allergies,
- Children who are hospitalized for at least 3 days
Who cannot join
- Hospitalized children under 6 years of age and over 12 years of age,
- Predicted discharge in less than 3 days,
- Children with a sleeping companion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sleep Companion Application on Psychosocial Symptoms in Hospitalized Children
The study was planned as a randomized controlled experimental study to investigate the effect of sleep companion application on psychosocial symptoms in hospitalized school children aged 6-12 years.
Read the detailed description
The sample of the study consisted of a total of 97 school-age children hospitalized in the Pediatrics and Pediatric Surgery-Endocrine Service of the Health Services Application and Research Hospital of a university hospital and in the Pediatrics Service of a state hospital. Children who met the inclusion criteria and whose written and verbal consent was obtained from their parents for participation in the study after being informed were included in the study.
The study was completed as 50 control and 47 experimental group with 3 missing persons in the experimental group.
Data were collected using the "Introductory Information Form" and "Psychosocial Symptoms Diagnostic Scale for Hospitalized Children (PSDS)" tools.
The toy, which was selected as a sleep companion for the children in the experimental group, was introduced to the children and accompanied them for 3 days during their hospitalization. The experimental and control groups were observed for psychosocial symptoms.
The data will be analyzed with SPSS software.
- Conditions
- Main Heading (Descriptor) Terms
- Being tested
- Sleep buddy
- Keywords
- hospital, child, sleep companion, psychosocial symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep buddyOther
The toy chosen as a sleep companion was introduced to the children in the experimental group and they were told that it would accompany them for 3 days during their hospitalization. Before giving the sleep companion, parents and children were informed about the sleep companion and their questions about the study were answered. Children who did not have their own sleep companion were included in the sample. The child was encouraged to sleep and spend time with the given sleep buddy and the family was also informed.
| Study group | Role | What they receive |
|---|---|---|
| Sleep buddy | Experimental | Children who did not have their own sleeping companion were given a toy selected as a sleeping companion. The toy was introduced to the children and accompanied them for 3 days during their hospitalization. Receives: Other: Sleep buddy |
| control group | No intervention | After the child in the control group was hospitalized in the clinic, routine hospitalization procedures were performed and no intervention was performed. The child was observed during the three days of hospitalization. It was observed that the children did not have their own toys with them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial symptoms diagnostic scale
Determination of psychosocial symptoms of hospitalized children The highest score that can be obtained from the scale is "48" and the lowest score is "0". A high score on the scale means that the hospitalized school child has psychosocial problems.
Measured: Used 3 days after the sleep companion app. The scale administration took 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start1 Jul 2023
- Primary completion30 Jan 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Main Heading (Descriptor) TermsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aysel kokcudogan, Istanbul Medipol University Hospital
- Investigators
- Aysel Kokcu Dogan, Ph.D, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508905
- Sponsor's protocol ID
- E-76728045-806.01.03-226794342
- Status last verified
- Apr 2026
- First submitted
- 15 Jul 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleep Companion Application on Psychosocial Symptoms in Hospitalized Children
- ClinicalTrials.gov ID
- NCT06508905
- Acronym / sponsor ID
- E-76728045-806.01.03-226794342
- Conditions
- Main Heading (Descriptor) Terms
- Keywords
- hospital, child, sleep companion, psychosocial symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 18 Jul 2024 (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.
The study was planned as a randomized controlled experimental study to investigate the effect of sleep companion application on psychosocial symptoms in hospitalized school children aged 6-12 years.
Detailed description
The sample of the study consisted of a total of 97 school-age children hospitalized in the Pediatrics and Pediatric Surgery-Endocrine Service of the Health Services Application and Research Hospital of a university hospital and in the Pediatrics Service of a state hospital. Children who met the inclusion criteria and whose written and verbal consent was obtained from their parents for participation in the study after being informed were included in the study.
The study was completed as 50 control and 47 experimental group with 3 missing persons in the experimental group.
Data were collected using the "Introductory Information Form" and "Psychosocial Symptoms Diagnostic Scale for Hospitalized Children (PSDS)" tools.
The toy, which was selected as a sleep companion for the children in the experimental group, was introduced to the children and accompanied them for 3 days during their hospitalization. The experimental and control groups were observed for psychosocial symptoms.
The data will be analyzed with SPSS software.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep buddy | Experimental | Other: Sleep buddyChildren who did not have their own sleeping companion were given a toy selected as a sleeping companion. The toy was introduced to the children and accompanied them for 3 days during their hospitalization. |
| control group | No intervention | –After the child in the control group was hospitalized in the clinic, routine hospitalization procedures were performed and no intervention was performed. The child was observed during the three days of hospitalization. It was observed that the children did not have their own toys with them. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Hospitalized school-age children (6-12 years old),
- No mental disability,
- Volunteer to participate in the research,
- No allergies,
- Children who are hospitalized for at least 3 days
Key exclusion criteria (3 listed)
- Hospitalized children under 6 years of age and over 12 years of age,
- Predicted discharge in less than 3 days,
- Children with a sleeping companion
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 |
|---|---|---|
| Sleep buddyThe toy chosen as a sleep companion was introduced to the children in the experimental group and they were told that it would accompany them for 3 days during their hospitalization. Before giving the sleep companion, parents and children were informed about the sleep companion and their questions about the study were answered. Children who did not have their own sleep companion were included in the sample. The child was encouraged to sleep and spend time with the given sleep buddy and the family was also informed. | Other | Sleep buddy |
Primary outcome
Psychosocial symptoms diagnostic scale
Time frame: Used 3 days after the sleep companion app. The scale administration took 15 minutes.
Determination of psychosocial symptoms of hospitalized children The highest score that can be obtained from the scale is "48" and the lowest score is "0". A high score on the scale means that the hospitalized school child has psychosocial problems.
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 8 Apr 2026.
- Individual participant dataSharing planned: No
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.
Aysel Kokcu Dogan, Ph.D study director
Medipol 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 Sleep buddy in people with Main Heading (Descriptor) Terms, run by Istanbul Medipol University Hospital 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 5 inclusion and 3 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 8 Apr 2026. 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?
Psychosocial symptoms diagnostic scale (time frame: Used 3 days after the sleep companion app. The scale administration took 15 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2026.