NCT06732544

Brief 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". 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

September 8, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

December 13, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

May 25, 2024

Last Update Submit

December 12, 2024

Conditions

Keywords

birth enviromentnewborn

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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).

    24 hours after birth

Study Arms (2)

experiment group

EXPERIMENTAL

These women will spend labor in the snoezelen room.

Other: snoezelen room

control group

OTHER

These women will spend the duration of labor in a standard delivery room.

Other: routine delivery room

Interventions

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.

experiment group

General practice

control group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University Hospital

Amasya, Amasya, 05100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2024

First Posted

December 13, 2024

Study Start

September 8, 2024

Primary Completion

March 30, 2025

Study Completion

April 30, 2025

Last Updated

December 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After the article was published

Locations