Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Standard Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator, PhD | Contact | +90 442 231 16 00 | sejder@atauni.edu.tr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kütahya City Hospital | Kütahya | 25000 | Turkey (Türkiye) |
Individual participant data will not be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Five parallel groups: sacral massage, lavender aromatherapy, Turkish makam music, aquarium visual stimulus, and control (standard care).
Not provided
Not provided
Outcome assessors and statisticians will be blinded to group assignments during data analysis.
| No Intervention |
Participants in the control group will receive routine obstetric care without any additional sensory interventions. |
| 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. |
|
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). |