NCT07652957

Brief Summary

Aim: This study aimed to evaluate the effects of Swedish massage combined with lavender and chamomile oils on childbirth outcomes during the first and second stages of labor. Materials and Methods: This randomized controlled experimental study was conducted with 90 pregnant women. Participants were randomly assigned to three groups: Intervention A (n=30; carrier oil + chamomile oil + Swedish massage), Intervention B (n=30; carrier oil + lavender oil + Swedish massage), and Control (n=30; carrier oil + Swedish massage). Data were collected using the Individual Identification Form, Vital Signs (blood pressure and pulse), Partograph, Visual Analog Scale (VAS) for pain, State-Trait Anxiety Inventory (STAI-I and STAI-II), and the Childbirth Fear Scale. Statistical analyses were performed using IBM SPSS Statistics Version 23.0. The study was designed to compare the effects of Swedish massage combined with chamomile oil, lavender oil, or carrier oil on labor pain, anxiety, childbirth fear, physiological parameters, and selected birth outcomes during the first and second stages of labor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

July 24, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 4, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 4, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

Painlaborchildbirth fearlavender oilChamomile oilSwedish massagearomatherapy

Outcome Measures

Primary Outcomes (1)

  • Labor pain intensity Visual Analog Scale

    Measurement tool: Visual Analog Scale Measurement time: 4 cm, 8 cm, 10 cm cervical dilation and immediately after delivery. The scale is a 10 cm long scale used to assess pain intensity. Scores range from 0-100; higher scores indicate more severe pain.

    During Childbirth ( to 24 hours)

Secondary Outcomes (3)

  • State anxiety level, state and trait anxiety scale I

    Duration of first and second stage of labor servical opening 4-6 cm (up to 6 hours)

  • Trait anxiety level, state and trait anxiety scale II

    Duration of first and second stage of labor servical opening 6-10 cm (up to 4 hours)

  • Delivery Fear Scale

    During the first and second stages of labor. (up to 24 hours)

Study Arms (3)

Intervention A,

EXPERIMENTAL

Intervention A (n=30; carrier oil + chamomile oil + Swedish massage), Stage I: From cervical dilation of 4 cm to 8 cm, four 10-minute sessions of labor massage were performed using superficial tapping techniques (for the head, shoulders, hands, and feet). Stage II: From 8 cm dilation to delivery, petrissage or strong tapping massage (B-shaped and heart-shaped), petrissage to the head and shoulders, spiral vibration to both sides of the vertebral column, and sacrum compression were applied four times for 20 minutes each. In each stage, the expectant mother was asked to indicate the area where she felt pain using the "Pain Area Drawings" chart. The type and intensity of the massage were determined based on the severity of the pain and the mother's emotional needs.

Other: Aromatherapy and Massage Care for labor pain management

Intervention B,

EXPERIMENTAL

Intervention B (n=30; carrier oil + lavender oil + Swedish massage) Stage I: From cervical dilation of 4 cm to 8 cm, four 10-minute sessions of labor massage were performed using superficial tapping techniques (for the head, shoulders, hands, and feet) Stage II: From 8 cm dilation to delivery, petrissage or strong tapping massage (B-shaped and heart-shaped), petrissage to the head and shoulders, spiral vibration to both sides of the vertebral column, and sacrum compression were applied four times for 20 minutes each. In each stage, the expectant mother was asked to indicate the area where she felt pain using the "Pain Area Drawings" chart. The type and intensity of the massage were determined based on the severity of the pain and the mother's emotional needs.

Other: Aromatherapy and Massage Care for labor pain management

Intervention C

EXPERIMENTAL

Control (n=30; carrier oil + Swedish massage).Stage I: From cervical dilation of 4 cm to 8 cm, four 10-minute sessions of labor massage were performed using superficial tapping techniques (for the head, shoulders, hands, and feet). Stage II: From 8 cm dilation to delivery, petrissage or strong tapping massage (B-shaped and heart-shaped), petrissage to the head and shoulders, spiral vibration to both sides of the vertebral column, and sacrum compression were applied four times for 20 minutes each. In each stage, the expectant mother was asked to indicate the area where she felt pain using the "Pain Area Drawings" chart. The type and intensity of the massage were determined based on the severity of the pain and the mother's emotional needs.

Other: Aromatherapy and Massage Care for labor pain management

Interventions

Although lavender and chamomile oils have been used in midwifery practices in previous studies, no study has been found comparing the effects of Swedish massage

Also known as: Aromatherapy Care Chamomile oil and swedish massage, Swedish massage and basic oil, Aromatherapy Care Lavender oil and swedish massage
Intervention A,Intervention B,Intervention C

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen were included because they were giving birth.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Voluntarily participate in the study and provide written consent.
  • Ability to communicate and follow instructions.
  • Possess a general health/obstetric status sufficient to safely complete the research process.
  • No known allergies to aromatherapy inhalation or skin reactions.

You may not qualify if:

  • Having a medical, psychiatric, or obstetric condition that could negatively affect the safety/validity of participation.
  • Being unsuitable for intervention due to conditions requiring acute/chronic treatment.
  • Using painkillers/sedatives, etc., that could affect the study results
  • Showing hypersensitivity to herbal/essential oils or carrier ingredients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Antalya City Hospital

Antalya, Center, 06000, Turkey (Türkiye)

Location

Antalya City Hospital

Antalya, Center, 43000, Turkey (Türkiye)

Location

Related Publications (1)

  • Durmaz Fatma Cigdem Sirin, Tosun Hülya, Özlü Aysun COMPARISON OF THE EFFECTS OF SWEDISH MASSAGE WITH NATURAL OILS DURING THE 1ST AND 2ND STAGES OF LABOR ON LABOR PAIN, FEAR AND ANXIETY LEVELS: A RANDOMIZED CONTROLLED STUDY . : . .

    RESULT

Related Links

MeSH Terms

Conditions

AgnosiaAnxiety DisordersPain

Interventions

AromatherapyAlkalies

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and ActivitiesInorganic Chemicals

Study Officials

  • Hulya t Tosun, Phd. FM.

    Kutahya Health Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A researcher overseeing the study's conduct is Dr. Ayten Yılmaz, a faculty member at Düzce University. She is Türkiye's first doctoral aromatherapist
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Randomise controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd. Faculty Member of Midwifery Dept. Thesis Consultant

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 17, 2026

Study Start

July 24, 2024

Primary Completion

January 14, 2025

Study Completion

May 19, 2025

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Can be shared between 27/08/2026 and 27/01/2030
Access Criteria
Researchers working at universities. Master's and doctoral students,
More information

Available IPD Datasets

Study Protocol (Fatma Cigdem Sirin Durmaz)Access

Locations