NCT07248787

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Dec 2025Jun 2027

First Submitted

Initial submission to the registry

November 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

November 17, 2025

Last Update Submit

November 23, 2025

Conditions

Labor PainBirth Satisfaction

Keywords

Labor painAromatherapyMassage therapyMusic therapyVisual stimulationComfortBirth satisfactionMulti-sensory interventionMidwiferySupportive care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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).

Study Arms (5)

Sacral Massage

EXPERIMENTAL

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

Lavender Aromatherapy

EXPERIMENTAL

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

Turkish Makam Music

EXPERIMENTAL

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

Aquarium Visual Stimulus

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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

Interventions

Sacral MassageBEHAVIORAL

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.

Sacral Massage
Lavender AromatherapyBEHAVIORAL

Lavender essential oil diffused for 20 minutes during each stage of labor (three times total) to promote calmness and reduce pain intensity.

Lavender Aromatherapy
Turkish Makam MusicBEHAVIORAL

Rehavi and Nihavend Turkish makam music (45-65 dB) played through headphones for 20 minutes during each stage of labor (three times total).

Turkish Makam Music
Aquarium Visual StimulusBEHAVIORAL

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

Aquarium Visual Stimulus

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya City Hospital

Kütahya, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Principal Investigator, PhD

CONTACT

+90 442 231 16 00sejder@atauni.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors and statisticians will be blinded to group assignments during data analysis.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Five parallel groups: sacral massage, lavender aromatherapy, Turkish makam music, aquarium visual stimulus, and control (standard care).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Midwife

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 25, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations

TU(1)