Labor PainMSI-LABORNCT07248787
Effect of Multi-Sensory Interventions on Labor Pain, Comfort, and Birth Satisfaction
A study testing Sacral Massage, Lavender Aromatherapy and Turkish Makam Music in people with Labor Pain and Birth Satisfaction, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Pain, Birth Satisfaction
- What is being tested?
- Sacral Massage, Lavender Aromatherapy and Turkish Makam Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kütahya City Hospital
Kütahya, 25000
Fatma Aybice Karaca, MSc, +905350825828, karacaaybice48@gmail.com
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Labor Pain, Birth Satisfaction
- Being tested
- Sacral Massage, Lavender Aromatherapy, Turkish Makam Music, Aquarium Visual Stimulus
- Keywords
- Labor pain, Aromatherapy, Massage therapy, Music therapy, Visual stimulation, Comfort, Birth satisfaction, Multi-sensory intervention, Midwifery, Supportive care
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral MassageBehavioural
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 AromatherapyBehavioural
Lavender essential oil diffused for 20 minutes during each stage of labor (three times total) to promote calmness and reduce pain intensity.
Turkish Makam MusicBehavioural
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 StimulusBehavioural
Continuous presentation of an aquarium scene video during the active phase of labor to provide visual distraction and relaxation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Aquarium Visual Stimulus |
| Standard Care | No intervention | Participants in the control group will receive routine obstetric care without any additional sensory interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor Pain Level
Pain intensity measured using a 10-cm VAS at three points in active labor.
Measured: Assessed at 4-5 cm, 6-7 cm, and 8-10 cm cervical dilation during active labor.
Secondary outcomes (3)
Comfort Level (Comfort Scale)
Maternal comfort during labor will be measured using the Comfort Scale developed by Kolcaba.
Measured: 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.
Measured: 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.
Measured: From 3 cm cervical dilation until delivery (up to approximately 12-18 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Five parallel groups: sacral massage, lavender aromatherapy, Turkish makam music, aquarium visual stimulus, and control (standard care).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Aybice Karaca, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248787
- Sponsor's protocol ID
- AtaU-EBE-MSI-RCT-2025
- Acronym
- MSI-LABOR
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multi-Sensory Interventions Applied to Pregnant Women on Labor Pain, Comfort, and Satisfaction
- ClinicalTrials.gov ID
- NCT07248787
- Acronym / sponsor ID
- MSI-LABOR / AtaU-EBE-MSI-RCT-2025
- Conditions
- Labor Pain, Birth Satisfaction
- Keywords
- Labor pain, Aromatherapy, Massage therapy, Music therapy, Visual stimulation, Comfort, Birth satisfaction, Multi-sensory intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- Five parallel groups: sacral massage, lavender aromatherapy, Turkish makam music, aquarium visual stimulus, and control (standard care).
| Arm | Type | Receives |
|---|---|---|
| Sacral Massage | Experimental | Behavioral: Sacral MassageParticipants 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. |
| Lavender Aromatherapy | Experimental | Behavioral: Lavender AromatherapyParticipants 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. |
| Turkish Makam Music | Experimental | Behavioral: Turkish Makam MusicParticipants 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. |
| Aquarium Visual Stimulus | Experimental | Behavioral: Aquarium Visual StimulusParticipants 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. |
| Standard Care | No intervention | –Participants in the control group will receive routine obstetric care without any additional sensory interventions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacral MassageA 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. | Behavioural | Sacral Massage |
| Lavender AromatherapyLavender essential oil diffused for 20 minutes during each stage of labor (three times total) to promote calmness and reduce pain intensity. | Behavioural | Lavender Aromatherapy |
| Turkish Makam MusicRehavi and Nihavend Turkish makam music (45-65 dB) played through headphones for 20 minutes during each stage of labor (three times total). | Behavioural | Turkish Makam Music |
| Aquarium Visual StimulusContinuous presentation of an aquarium scene video during the active phase of labor to provide visual distraction and relaxation. | Behavioural | Aquarium Visual Stimulus |
Primary outcome
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.
3 secondary outcomes
Comfort Level (Comfort Scale)
Time frame: At 8-9 cm cervical dilation during active labor
Birth Satisfaction (Birth Satisfaction Scale)
Time frame: Up to 2 hours postpartum.
Labor Duration
Time frame: From 3 cm cervical dilation until delivery (up to approximately 12-18 hours).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral Massage, Lavender Aromatherapy and Turkish Makam Music in people with Labor Pain and Birth Satisfaction, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator, PhD (+90 442 231 16 00, sejder@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labor Pain Level (time frame: Assessed at 4-5 cm, 6-7 cm, and 8-10 cm cervical dilation during active labor.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.