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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Labor Pain; Birth Satisfaction
• Intervention / Treatment: Behavioral: Sacral Massage; Behavioral: Lavender Aromatherapy; Behavioral: Turkish Makam Music; Behavioral: Aquarium Visual Stimulus

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Principal Investigator, PhD; Phone Number: +90 442 231 16 00; Email: sejder@atauni.edu.tr

Study Locations

• Turkey (Türkiye)
  • Kütahya, Turkey (Türkiye), 25000
    • Kutahya City Hospital
    • Contact: Fatma Aybice Karaca, MSc; Phone Number: +905350825828; Email: karacaaybice48@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: Lavender Aromatherapy; Lavender essential oil diffused for 20 minutes during each stage of labor (three times total) to promote calmness and reduce pain intensity.
Experimental: 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.	Behavioral: 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).
Experimental: 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.	Behavioral: Aquarium Visual Stimulus; Continuous presentation of an aquarium scene video during the active phase of labor to provide visual distraction and relaxation.
No Intervention: Standard Care; Participants in the control group will receive routine obstetric care without any additional sensory interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labor Pain Level	Pain intensity measured using a 10-cm VAS at three points in active labor.	Assessed at 4-5 cm, 6-7 cm, and 8-10 cm cervical dilation during active labor.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort Level (Comfort Scale)	Maternal comfort during labor will be measured using the Comfort Scale developed by Kolcaba.	At 8-9 cm cervical dilation during active labor
Birth Satisfaction (Birth Satisfaction Scale)	Maternal satisfaction with the childbirth experience will be evaluated using the Birth Satisfaction Scale (BSS) approximately 2 hours after delivery. Higher scores indicate greater satisfaction.	Up to 2 hours postpartum.
Labor Duration	Total duration of labor (minutes) will be calculated as the time from 3 cm cervical dilation to delivery.	From 3 cm cervical dilation until delivery (up to approximately 12-18 hours).

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Labor pain; Massage therapy; Aromatherapy; Music therapy; Comfort; Midwifery; Supportive care; Birth satisfaction; Visual stimulation; Multi-sensory intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Labor Pain
• Other Study ID Numbers: AtaU-EBE-MSI-RCT-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No