HealthyNCT06732544
Effect of Multisensory (Snoezelen) Environment on Birth Outcomes
A study testing snoezelen room and routine delivery room in people with Healthy, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
Giving birth is a fundamental life event that women will remember throughout their lives. While seeking perfection for the birth environment, much can be learned from other areas of expertise and different pursuits can be undertaken. An example of this is "Snoezelen rooms". Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- snoezelen room and routine delivery room
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Sep 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who are between the ages of 18-35
- Having a singleton pregnancy between 38-42 weeks of pregnancy
- Primiparous
- Labor started spontaneously
- In the latent phase of labor
- Without uterine contraction anomaly
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- The leading part of the fetus is the head (in vertex position)
- No analgesia was applied
- There is no indication for cesarean section
- Amniotomy is not performed
- Fetal weight over 2500 g, fetal weight not over 4000 gr
- Pregnant women who do not have communication problems will be included in the study.
Who cannot join
- Reporting hearing, vision, smell and balance problems
- Allergy, asthma, COPD, migraine, vertigo, epilepsy, etc.
- Declaring that they have a chronic disease
- Declaring that they have a psychiatric history or a diagnosed psychological disorder
- Declaring that they have a risky health condition related to pregnancy (preeclampsia, gestational DM, etc.),
- Those who report smoking, alcohol and/or substance use
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- Reports that he/she has sensory sensitivity
- Declaring an allergy to lavender (Lavandula angustifolia Mill.) or lavender oil
- Declaring that there is a person with special needs in the family
- Participated in the study voluntarily and then gave up
- Pregnant women who develop any possible side effects during the study will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Amasya University Hospital
Amasya, Amasya, 05100
About this study
Official title: Effect of Multisensory (Snoezelen) Environment on Birth Outcomes, Newborn Health Parameters and Birth Memory: Randomized Controlled Study
Giving birth is a fundamental life event that women will remember throughout their lives. While seeking perfection for the birth environment, much can be learned from other areas of expertise and different pursuits can be undertaken. An example of this is "Snoezelen rooms". In the Snoezelen environment, it is aimed to relax the woman by stimulating various senses, including visual and auditory, and by diverting attention. The room design is a combination of light music, aquarium, optical illusions and aromatic oils. This study will be conducted in a randomized controlled manner to examine the effects of a multi-sensory (snoezelen) environment on birth outcomes, newborn health parameters and birth memory.
- Conditions
- Healthy
- Being tested
- snoezelen room, routine delivery room
- Keywords
- birth enviroment, newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
snoezelen roomOther
During the travail, projectors, starry ceiling visuals and blue light LEDs will be used for visual stimuli, speakers will be used as auditory stimuli, diffusers will be used for olfactory stimuli, and therapy dough will be used for touch stimuli.
routine delivery roomOther
General practice
| Study group | Role | What they receive |
|---|---|---|
| experiment group | Experimental | These women will spend labor in the snoezelen room. Receives: Other: snoezelen room |
| control group | Other | These women will spend the duration of labor in a standard delivery room. Receives: Other: routine delivery room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal information form
With this form, developed by the researcher taking into account literature knowledge, data on women\'s demographic information such as age, education level, and obstetric characteristics such as whether the pregnancy is planned and the current gestational week will be obtained (Hauck et al., 2008; Manesh et al. 2015).
Measured: on admission to the hospital
birth follow-up form
With the follow-up form prepared to evaluate the birth process using the literature, the duration of the stages during labor and the synthetic oxytocin status used will be evaluated. While these practices are evaluated, the researcher will be present in the environment only as an observer, and the practices determined as a result of the observation will be noted on the Birth Monitoring Form (Olcese et al., 2013 Momeni et al., 2020).
Measured: at the beginning of the third stage of childbirth
Birth Memory and Recall Scale
In order to evaluate women\'s postpartum birth memories, their birth memories, and their experiences regarding birth memories, DHHÖ conducted a study by Foley et al. (2014). It was adapted into Turkish by Topkara \& Çağan (2021).
Measured: 24 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start8 Sep 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732544
- Sponsor's protocol ID
- AU_Eliftez
- Status last verified
- Nov 2024
- First submitted
- 25 May 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multisensory (Snoezelen) Environment on Birth Outcomes, Newborn Health Parameters and Birth Memory: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06732544
- Acronym / sponsor ID
- AU_Eliftez
- Conditions
- Healthy
- Keywords
- birth enviroment, newborn
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 8 Sep 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 13 Dec 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.
Giving birth is a fundamental life event that women will remember throughout their lives. While seeking perfection for the birth environment, much can be learned from other areas of expertise and different pursuits can be undertaken. An example of this is "Snoezelen rooms". In the Snoezelen environment, it is aimed to relax the woman by stimulating various senses, including visual and auditory, and by diverting attention. The room design is a combination of light music, aquarium, optical illusions and aromatic oils. This study will be conducted in a randomized controlled manner to examine the effects of a multi-sensory (snoezelen) environment on birth outcomes, newborn health parameters and birth memory.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group | Experimental | Other: snoezelen roomThese women will spend labor in the snoezelen room. |
| control group | Other | Other: routine delivery roomThese women will spend the duration of labor in a standard delivery room. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Those who are between the ages of 18-35
- Having a singleton pregnancy between 38-42 weeks of pregnancy
- Primiparous
- Labor started spontaneously
- In the latent phase of labor
Key exclusion criteria (11 listed)
- Reporting hearing, vision, smell and balance problems
- Allergy, asthma, COPD, migraine, vertigo, epilepsy, etc.
- Declaring that they have a chronic disease
- Declaring that they have a psychiatric history or a diagnosed psychological disorder
- Declaring that they have a risky health condition related to pregnancy (preeclampsia, gestational DM, etc.),
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 |
|---|---|---|
| snoezelen roomDuring the travail, projectors, starry ceiling visuals and blue light LEDs will be used for visual stimuli, speakers will be used as auditory stimuli, diffusers will be used for olfactory stimuli, and therapy dough will be used for touch stimuli. | Other | experiment group |
| routine delivery roomGeneral practice | Other | control group |
Primary outcome
Personal information form
Time frame: on admission to the hospital
With this form, developed by the researcher taking into account literature knowledge, data on women\'s demographic information such as age, education level, and obstetric characteristics such as whether the pregnancy is planned and the current gestational week will be obtained (Hauck et al., 2008; Manesh et al. 2015).
birth follow-up form
Time frame: at the beginning of the third stage of childbirth
With the follow-up form prepared to evaluate the birth process using the literature, the duration of the stages during labor and the synthetic oxytocin status used will be evaluated. While these practices are evaluated, the researcher will be present in the environment only as an observer, and the practices determined as a result of the observation will be noted on the Birth Monitoring Form (Olcese et al., 2013 Momeni et al., 2020).
Birth Memory and Recall Scale
Time frame: 24 hours after birth
In order to evaluate women\'s postpartum birth memories, their birth memories, and their experiences regarding birth memories, DHHÖ conducted a study by Foley et al. (2014). It was adapted into Turkish by Topkara \& Çağan (2021).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Yes
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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 snoezelen room and routine delivery room in people with Healthy, run by Amasya 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 12 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 13 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Personal information form (time frame: on admission to the hospital). 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?
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 13 Dec 2024.