Effect of Snoezelen Room on Birth Process

NCT06984614 | Recruiting

• 1 other identifier: 35864
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Birth Outcomes; Birth

Keywords

midwifery; birth process; snoezelen room; fear of birth; birth satisfaction; pregnancy

Outcome Measures

Primary Outcomes (3)

• Fear of Childbirth Scale:

  The fear of childbirth scale was developed by K. Wijma, S. Alehagen and B. Wijma (2002) to measure fear experienced during labor. The scale consists of ten items and expectant mothers score each item between 1 and 10 (1= I completely disagree, 10= I completely agree). The minimum score that can be obtained from the scale is 10, and the maximum score is 100. A high score indicates high fear. It is a very practical scale in terms of application. 5 items (1, 3, 5, 7, 10) are positive and 5 items (2, 4, 6, 8, 9) are negative. The 5 items with positive meanings are reverse scored. Since childbirth is a process in which women are both psychologically and physically intense, the scale can be answered in 30-60 seconds, during each phase of labor. The Cronbach alpha value of the original scale was found to be 0.88. The Turkish adaptation was made by Gökçe İşbir, Serçekuş and İnci (2017) and the Cronbach alpha value was determined as 0.90.

  One hour

• Childbirth Comfort Scale

  Originally named "Childbirth Comfort Questionnaire", it was developed by Kerri Durnell Schuiling in 2003, inspired by Kolcaba's comfort theory. Schuiling, Sampslelle and Kolcaba's study (2011) applied the scale to 64 pregnant women in the latent phase in the delivery room. The Cronbach alpha of the scale was 0.71, and as a result of the factor analysis, 4 factors were found in its structure, namely physical, environmental, psychospiritual and sociocultural. The lowest score that can be obtained from the scale is 14, the highest is 70. As a result of the Turkish validity and reliability study of the Childbirth Comfort Questionnaire by Potur Coşkuner et al. (2015), it was determined that the form with a 3-factor structure was reduced to 9 items and could be used to evaluate the comfort level of women during birth, and that it was a valid and reliable scale for our country. Cronbach alpha was found to be 0.75. In the Turkish version, the lowest possible

  Eight hour

• VAS:

  Visual Analog Scale (VAS) was developed by Dr. Akbay A. to convert some values that cannot be measured numerically into numerical values. The two extreme definitions of the parameter to be evaluated are written on both ends of a line divided into ten 100 mm segments, and the patient is asked to indicate where his/her own situation fits on this line by drawing a line, putting a dot, or pointing. One end of the line indicates no pain, while the other end indicates very severe pain. The patient is asked to indicate the state of his/her pain in the situation he/she is in on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain. The test has an important advantage that it does not have a language and is easy to apply (Sakorntanun et al. 2012). Will be used to describe the pregnant woman's pain during labor.

  One hour

Secondary Outcomes (2)

• Birth Satisfaction Scale:

  two hours after birth

• β-Endorphin Level Analysis:

  One hour

Study Arms (2)

Snoezelen room

EXPERIMENTAL

The primiparous pregnant women selected for the intervention group will be taken to the Snoezelen delivery room and the researcher will observe during this process. First, the "Pregnancy 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 every hour and the average pain level during labor will be determined. The "Fear of Childbirth Scale" will be applied when the pregnant woman's cervical dilation is 3 cm and above, the "Birth Comfort Scale" 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; intravenous blood samples will be taken 3 times: when the cervical dilation is 3 cm, 10 cm, and after the birth of the placenta. The Beta Endorphin Level Recording Form will be filled.

Other: Snoezelen room

Standart care room

NO INTERVENTION

The primiparous pregnant women selected for the control group will be taken to the standard delivery room and routine practices will not be deviated from in the hospital. First, the "Pregnant Information Form" 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 every hour and the average pain level during labor will be determined. The "Fear of Childbirth Scale" will be applied when the pregnant woman's cervical dilation is 3 cm and above, the "Birth Comfort Scale" 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 the beta endorphin levels; intravenous blood samples will be taken 3 times: when the cervical dilation is 3 cm, 10 cm, and after the birth of the placenta. The "Beta Endorphin Level Recording Form" will be filled.

Interventions

Snoezelen room OTHER

'Snoezelen room' is a meaning a room designed to stimulate people's senses. The history of the Snoezelen room dates back to people with mild or severe disabilities. It provides muscle relaxation for people with severe pain. This has become part of complementary medicine that promotes effective comfort and relaxation, which causes the release of endorphins and alleviates a person's capacity to cope with pain. The Snoezelen environment can be used to distract from pain by focusing on various senses, including visual and auditory. Describing multi-sensory therapeutic activity in a special room filled with stimuli that aim to stimulate all senses provides participants with feelings of relaxation and self-control (Nielsen, Overgaard, 2020; Jamshidi Manesh et. al., 2015; Anderson et. al.2011). In the study, the Snoezelen room was designed and the pregnant women in the intervention group will complete their labor in this room, while the control group will complete their labor in the

Snoezelen room

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sakarya University: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Sakarya Training and Research Hospital, Maternity Campus

Sakarya, Turkey (Türkiye)

RECRUITING

Study Officials

• Melek Balçık Çolak

  Sakarya University

  STUDY DIRECTOR

Central Study Contacts

Melek Balçık Çolak, RM, PhD, Asst. Prof.

CONTACT

+90 264-295-3881; mbalcikcolak@sakarya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: May 22, 2025
• Study Start: January 11, 2025
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)