Effect of Multi-Sensory Interventions on Labor Pain, Comfort, and Birth Satisfaction (MSI-LABOR)

Ataturk University

Status: Not yet enrolling

Conditions: Labor Pain; Birth Satisfaction

Treatments: Behavioral: Aquarium Visual Stimulus; Behavioral: Lavender Aromatherapy; Behavioral: Turkish Makam Music; Behavioral: Sacral Massage

Study type: Interventional

Funder types: Other

Identifiers

NCT07248787

AtaU-EBE-MSI-RCT-2025

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 5 patient groups

Sacral Massage

Experimental group

Description:

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.

Treatment:

Behavioral: Sacral Massage

Lavender Aromatherapy

Experimental group

Description:

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.

Treatment:

Behavioral: Lavender Aromatherapy

Turkish Makam Music

Experimental group

Description:

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.

Treatment:

Behavioral: Turkish Makam Music

Aquarium Visual Stimulus

Experimental group

Description:

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.

Treatment:

Behavioral: Aquarium Visual Stimulus

Standard Care

No Intervention group

Description:

Participants in the control group will receive routine obstetric care without any additional sensory interventions.