Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07248787

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Labor Pain Birth Satisfaction Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sacral Massage

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

Continuous presentation of an aquarium scene video during the active phase of labor to provide visual distraction and relaxation.

Primary outcomes

  1. Labor Pain Level

    Time frame: 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.

Secondary outcomes

  1. Comfort Level (Comfort Scale)

    Time frame: At 8-9 cm cervical dilation during active labor

    Maternal comfort during labor will be measured using the Comfort Scale developed by Kolcaba.

  2. Birth Satisfaction (Birth Satisfaction Scale)

    Time frame: Up to 2 hours postpartum.

    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.

  3. Labor Duration

    Time frame: From 3 cm cervical dilation until delivery (up to approximately 12-18 hours).

    Total duration of labor (minutes) will be calculated as the time from 3 cm cervical dilation to delivery.

Study contacts

Contact information is provided by the study sponsor or research team.

Principal Investigator, PhD

CONTACT

[email protected]

+90 442 231 16 00

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Acronym: MSI-LABOR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.