Clinical trial NCT06984614: Effect of Snoezelen Room on Birth Process
Official title: Effect of Snoezelen Room on Birth Process: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Birth Outcomes
Birth
Keywords: midwifery
birth process
snoezelen room
fear of birth
birth satisfaction
pregnancy
Lead sponsor: Sakarya University
Sponsor class: OTHER
Collaborators: name: Health Institutes of Turkey
First posted: 2025-05-22
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aromatherapy, visual and auditory stimuli are used together in the Snoezelen room. Aromatherapy increases the production of endorphins, reduces the intensity of pain and distracts the attention from the pain. Music also blocks the transmission of nerve impulses to the spinal cord.Considering these effects, the study emerges as a new technology for the midwifery field in our country. Although the use of snoezelen rooms in the delivery environment is becoming increasingly widespread abroad, it has not been used in delivery services in any hospital in our country. The primary purpose of this study is to convert a room in the delivery room of the hospital into a Snoezelen room and have women complete their delivery process in this room, and the secondary purpose is to determine the effect of the Snoezelen room on the delivery process.

The primiparous pregnant women selected for the intervention and control groups will be informed about the purpose of the study and the applications by the research midwife or gynecologist following the birth and will be administered the "Pregnant Information Form", "Visual Analog Scale (VAS)", "Fear of Childbirth Scale", "Birth Comfort Scale", and after birth, the "Birth Information Form", "Birth Satisfaction Scale". The Beta Endorphin Level Recording Form will be filled out.

Detailed description: This study is a randomized controlled trial to evaluate the effect of the snoezelen room on the delivery process. This clinical trial will be registered on ClinicalTrials.gov. Reporting will be carried out in accordance with CONSORT for parallel group randomized studies. (CONSORT 2010, Access date: June 10, 2023). The study is planned to be conducted in the delivery room of Sakarya Education and Research Hospital, Gynecology and Pediatrics Service Building between October 2023 and July 2024. The reason for choosing this hospital for the study is that it is the only hospital in Sakarya with a fully equipped Gynecology and Obstetrics unit for delivery.

Intervention Group Implementation Steps The primiparous pregnant women selected for the intervention group will be informed about the purpose of the study and the applications by the researcher midwife or gynecologist following the birth and if they accept to participate in the study voluntarily, their written consent will be obtained, then they will be taken to the Snoezelen delivery room and the researcher will observe during this process. First, the "Pregnant Information Form" will be used, and the "Visual Analog Scale (VAS)" will be used to describe the pain of the pregnant woman during labor. In addition, the "VAS" will be asked and filled in every hour and the average pain level during labor will be determined. The "Fear of Childbirth Scale" will be applied when the cervical dilation of the pregnant woman is 3 cm and above, the "Birth Comfort Scale" will be applied when the cervical dilation is 8 cm, the "Birth Information Form" will be applied after birth, and the "Birth Satisfaction Scale" will be applied two hours after birth. In order to determine beta-endorphin levels; when the cervical dilation is 3 cm. and 10 cm. Intravenous blood samples will be taken 3 times, one during pregnancy and one after the birth of the placenta. The Beta Endorphin Level Record Form will be filled out.

Control Group Application Steps Primiparous pregnant women selected for the control group will be taken to the standard delivery room after being informed about the purpose of the study and the practices, and if they voluntarily agree to participate in the study, their written consent will be obtained, and routine practices in the hospital will not be deviated from. In order to ensure that there is no difference between the groups in terms of episiotomy and delivery techniques, women who are followed and delivered by the same midwife will be included in the study. The same forms will be used in the intervention group.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who are planned to give birth vaginally in their 37th-42nd weeks of pregnancy,
* who are in their first pregnancy, who do not have any vision,
* hearing or communication problems,
* who can speak Turkish and express themselves in Turkish,
* who volunteer will be included in the study.

Exclusion Criteria:

* Women with multiple pregnancies,
* women who are planned to give birth by cesarean section,
* women who give birth by cesarean section for any reason during the study,
* women who develop any complications during pregnancy,
* women with chronic diseases,
* women with verbal, mental, etc. communication disabilities will not be included in the study.
* Women who have instrumental delivery (with vacuum or forceps),
* postpartum complications in the newborn, or complications related to episiotomy (such as 3rd and 4th degree laceration, hematoma) from the control or intervention groups will be excluded from the study.

Primary outcomes:
measure: Fear of Childbirth Scale:
timeFrame: One hour
measure: Childbirth Comfort Scale
timeFrame: Eight hour
measure: VAS:
timeFrame: One hour
Secondary outcomes:
measure: Birth Satisfaction Scale:
timeFrame: two hours after birth
measure: β-Endorphin Level Analysis:
timeFrame: One hour
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya Training and Research Hospital, Maternity Campus
Study officials:
affiliation: Sakarya University
name: Melek Balçık Çolak
role: STUDY_DIRECTOR
References: