- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06732544
Effect of Multisensory (Snoezelen) Environment on Birth Outcomes
December 12, 2024 updated by: Amasya University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Amasya, Turkey, 05100
- Amasya University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experiment group
These women will spend labor in the snoezelen room.
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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.
|
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Other: control group
These women will spend the duration of labor in a standard delivery room.
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General practice
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
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on admission to the hospital
|
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birth follow-up form
Time Frame: at the beginning of the third stage of childbirth
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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).
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at the beginning of the third stage of childbirth
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Birth Memory and Recall Scale
Time Frame: 24 hours after birth
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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).
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24 hours after birth
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 8, 2024
Primary Completion (Estimated)
March 30, 2025
Study Completion (Estimated)
April 30, 2025
Study Registration Dates
First Submitted
May 25, 2024
First Submitted That Met QC Criteria
December 12, 2024
First Posted (Estimated)
December 13, 2024
Study Record Updates
Last Update Posted (Estimated)
December 13, 2024
Last Update Submitted That Met QC Criteria
December 12, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AU_Eliftez
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Time Frame
After the article was published
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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