Effect of Multi-Sensory Interventions Applied to Pregnant Women on Labor Pain, Comfort, and Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Labor Pain Level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors and statisticians will be blinded to group assignments during data analysis.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sacral Massage (Behavioral)
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.
干预措施: Lavender Aromatherapy (Behavioral)
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.
干预措施: Turkish Makam Music (Behavioral)
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.
干预措施: Aquarium Visual Stimulus (Behavioral)
Standard Care
Participants in the control group will receive routine obstetric care without any additional sensory interventions.
结局指标
主要结局
Labor Pain Level
时间窗: Assessed at 4-5 cm, 6-7 cm, and 8-10 cm cervical dilation during active labor.
Pain intensity measured using a 10-cm VAS at three points in active labor.
次要结局
- Comfort Level (Comfort Scale)(At 8-9 cm cervical dilation during active labor)
- Birth Satisfaction (Birth Satisfaction Scale)(Up to 2 hours postpartum.)
- Labor Duration(From 3 cm cervical dilation until delivery (up to approximately 12-18 hours).)
研究者
Fatma Aybice Karaca
Midwife
Ataturk University