Effect of Multi-Sensory Interventions on Labor Pain, Comfort, and Birth Satisfaction

Официальное название

Effect of Multi-Sensory Interventions Applied to Pregnant Women on Labor Pain, Comfort, and Satisfaction

Обзор

The goal of this clinical trial is to learn whether different multi-sensory methods can help lower labor pain and improve comfort and birth satisfaction among pregnant women giving birth vaginally. 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.

Подробное описание

This study investigates the effects of four non-pharmacological, multi-sensory interventions-sacral massage, lavender aromatherapy, Turkish makam music, and aquarium visual stimulation-on key intrapartum outcomes. The trial uses a five-arm, parallel-group, randomized design conducted in the obstetrics clinic of Kütahya City Hospital.

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.

Вмешательства

• Поведенческое 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.
• Поведенческое Lavender Aromatherapy
  Lavender essential oil diffused for 20 minutes during each stage of labor (three times total) to promote calmness and reduce pain intensity.
• Поведенческое 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).
• Поведенческое Aquarium Visual Stimulus
  Continuous presentation of an aquarium scene video during the active phase of labor to provide visual distraction and relaxation.

Первичные конечные точки

• Labor Pain Level [Срок оценки: Assessed at 4-5 cm, 6-7 cm, and 8-10 cm cervical dilation during active labor.]

Вторичные конечные точки (3)

• Comfort Level (Comfort Scale) [Срок оценки: At 8-9 cm cervical dilation during active labor]
• Birth Satisfaction (Birth Satisfaction Scale) [Срок оценки: Up to 2 hours postpartum.]
• Labor Duration [Срок оценки: From 3 cm cervical dilation until delivery (up to approximately 12-18 hours).]

Критерии участия

Критерии включения

• Pregnant women aged 18 to 40 years
• 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

Критерии исключения

• Diagnosed high-risk pregnancy (e.g., preeclampsia, placenta previa, fetal distress)
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Kütahya City Hospital — Kütahya

Идентификаторы

NCT: NCT07248787 · AtaU-EBE-MSI-RCT-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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