Effect of Multi-Sensory Interventions on Labor Pain, Comfort, and Birth Satisfaction
NCT ID: NCT07248787
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-12-01
2027-06-30
Brief Summary
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The main questions this study aims to answer are:
Do supportive methods such as massage, lavender aromatherapy, Turkish makam music, or aquarium visual stimulation help women feel less labor pain compared to standard care?
Do these methods increase women's comfort and satisfaction during labor?
Participants will be randomly assigned to one of five groups:
Sacral massage group - will receive 10-minute sacral massages three times during labor.
Lavender aromatherapy group - will inhale lavender essential oil through a diffuser for 20 minutes, three times during labor.
Music therapy group - will listen to Turkish makam music (Rehavi or Nihavend) for 20 minutes, three times during labor.
Visual stimulation group - will watch a live aquarium image continuously during active labor.
Control group - will receive standard maternity care only.
All participants will give informed consent and receive care in the obstetrics unit of Kütahya City Hospital, Türkiye.
Researchers will measure:
Labor pain intensity at 4-5 cm, 6-7 cm, and 8-10 cm cervical dilatation using a Visual Analogue Scale (VAS).
Comfort level at 8-9 cm using the Comfort Characteristics Questionnaire (CCQ).
Birth satisfaction about 2 hours after delivery using the Birth Satisfaction Scale (BSS).
Labor duration will also be recorded.
This study will help determine which sensory methods are most effective and comfortable for pregnant women, and may guide supportive care practices during childbirth.
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Detailed Description
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Participants will be randomly assigned using sealed, opaque envelopes. All sensory interventions will be applied during the active and transitional phases of labor by trained midwives following standardized procedures. Outcome assessment will be performed by personnel blinded to group allocation to minimize bias.
The rationale for the selected sensory interventions is based on their proposed ability to modulate pain perception, enhance relaxation, and support emotional well-being through tactile, olfactory, auditory, or visual pathways. Each method has been previously used in maternity care, though comparative evidence in a multi-arm design is limited.
The study will evaluate the safety, feasibility, and relative effectiveness of these interventions within routine clinical practice. Analyses will follow the intention-to-treat principle. Standard comparative tests (e.g., ANOVA and repeated-measures models) will be used to examine differences in pain trajectories and other outcomes across the five groups.
The findings aim to generate clinically relevant evidence supporting the integration of culturally appropriate sensory strategies into intrapartum care to enhance women's childbirth experiences.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Sacral Massage
Participants in this group will receive a 10-minute sacral massage during each stage of labor (three times in total) by a trained midwife using circular hand movements over the sacral area to relieve labor pain.
Sacral Massage
A 10-minute sacral massage applied by a trained midwife during each stage of labor (three sessions in total). The massage involves circular hand motions to relieve pain and promote relaxation.
Lavender Aromatherapy
Participants in this group will receive lavender aromatherapy through a diffuser for 20 minutes during each stage of labor (three times in total). A few drops of pure lavender essential oil will be added to distilled water in a diffuser to promote relaxation and reduce pain perception.
Lavender Aromatherapy
Lavender essential oil diffused for 20 minutes during each stage of labor (three times total) to promote calmness and reduce pain intensity.
Turkish Makam Music
Participants will listen to selected Turkish Makam music (Rehavi and Nihavend) played at 45-65 dB for 20 minutes during each stage of labor (three times in total). Music will be delivered via headphones in a quiet environment to enhance comfort and emotional well-being.
Turkish Makam Music
Rehavi and Nihavend Turkish makam music (45-65 dB) played through headphones for 20 minutes during each stage of labor (three times total).
Aquarium Visual Stimulus
Participants will watch a video of an aquarium scene (fish swimming calmly) displayed on a screen throughout the active phase of labor to provide a soothing visual focus and reduce anxiety.
Aquarium Visual Stimulus
Continuous presentation of an aquarium scene video during the active phase of labor to provide visual distraction and relaxation.
Standard Care
Participants in the control group will receive routine obstetric care without any additional sensory interventions.
No interventions assigned to this group
Interventions
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Sacral Massage
A 10-minute sacral massage applied by a trained midwife during each stage of labor (three sessions in total). The massage involves circular hand motions to relieve pain and promote relaxation.
Lavender Aromatherapy
Lavender essential oil diffused for 20 minutes during each stage of labor (three times total) to promote calmness and reduce pain intensity.
Turkish Makam Music
Rehavi and Nihavend Turkish makam music (45-65 dB) played through headphones for 20 minutes during each stage of labor (three times total).
Aquarium Visual Stimulus
Continuous presentation of an aquarium scene video during the active phase of labor to provide visual distraction and relaxation.
Eligibility Criteria
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Inclusion Criteria
* Gestational age ≥ 37 weeks (term pregnancy)
* Singleton pregnancy with cephalic presentation
* Expected vaginal delivery
* Cervical dilation of at least 3 cm at hospital admission
* Able to communicate in Turkish and provide informed consent
Exclusion Criteria
* History of cesarean section or uterine surgery
* Use of epidural, spinal anesthesia, or opioid analgesics during labor
* Visual, auditory, or olfactory impairments that may affect perception of the interventions
* Allergy or sensitivity to lavender oil
* Emergency cesarean section or any complication requiring medical intervention
* Refusal or withdrawal of consent at any stage
18 Years
40 Years
FEMALE
No
Sponsors
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Ataturk University
OTHER
Responsible Party
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Fatma Aybice Karaca
Midwife
Locations
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Kütahya City Hospital
Kütahya, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AtaU-EBE-MSI-RCT-2025
Identifier Type: -
Identifier Source: org_study_id
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