Aromatherapy and Massage After Cesarean Delivery: A Randomized Controlled Trial

NCT07743736 | Recruiting

• 1 other identifier: 958-958-26
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean delivery is a common surgical procedure associated with postoperative pain, anxiety, and reduced maternal comfort during the early postpartum period. Non-pharmacological interventions such as aromatherapy and massage have been suggested as supportive approaches for improving maternal well-being; however, further evidence is needed regarding their effectiveness after cesarean delivery. This randomized controlled trial aims to evaluate the effects of aromatherapy inhalation and aromatherapy-assisted back massage on postoperative pain, anxiety, and postpartum comfort in women after cesarean delivery. Participants who meet the eligibility criteria will be randomly assigned to three groups: an aromatherapy inhalation group, an aromatherapy-assisted back massage group, and a placebo group receiving sterile water inhalation as a simulation. Interventions will be initiated after cesarean delivery, and outcomes will be assessed using the Visual Analog Scale for pain intensity, the State-Trait Anxiety Inventory for anxiety level, and the Postpartum Comfort Scale for comfort level. This study is expected to provide information about the potential contribution of complementary non-pharmacological interventions to maternal recovery after cesarean delivery.

Conditions

Postoperative Pain, Anxiety, and Postpartum Comfort After Cesarean Delivery

Keywords

Cesarean delivery; Postoperative pain; Aromatherapy; Postpartum comfort; Randomized controlled trial; Anxiety

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  Pain intensity will be assessed using the Visual Analog Scale (VAS), a 0-10 scale in which higher scores indicate greater pain intensity.

  From 6 to 42 hours after cesarean delivery (before and after each intervention session)

Secondary Outcomes (2)

• Anxiety level

  Before the first intervention session and after the final intervention session (42 hours after cesarean delivery).

• Postpartum comfort level

  Before the first intervention session and after the final intervention session (42 hours after cesarean delivery).

Study Arms (3)

Aromatherapy Inhalation Group

EXPERIMENTAL

Participants in this group will receive aromatherapy inhalation beginning at the 6th postoperative hour after cesarean delivery. The intervention will be administered at 6, 18, 30, and 42 hours after surgery using Rosa damascena essential oil according to the study protocol. Pain, anxiety, and postpartum comfort outcomes will be assessed before and after the intervention sessions according to the study protocol.

Behavioral: Aromatherapy Inhalation

Aromatherapy-Assisted Back Massage Group

EXPERIMENTAL

Participants in this group will receive aromatherapy-assisted back massage starting at the 6th postoperative hour after cesarean delivery. The intervention will be administered at 6, 18, 30, and 42 hours after surgery. Back massage will be performed using Rosa damascena essential oil diluted with a carrier oil according to the study protocol. Pain, anxiety, and postpartum comfort outcomes will be assessed before and after each intervention session.

Behavioral: Aromatherapy-Assisted Back Massage

Placebo Group

PLACEBO COMPARATOR

Participants in this group will receive placebo inhalation beginning at the 6th postoperative hour after cesarean delivery. The intervention will be administered at 6, 18, 30, and 42 hours after surgery using sterile water as a simulation of aromatherapy according to the study protocol. Pain, anxiety, and postpartum comfort outcomes will be assessed before and after the intervention sessions according to the study protocol.

Behavioral: placebo inhalation

Interventions

Aromatherapy Inhalation BEHAVIORAL

Participants will receive aromatherapy inhalation using Rosa damascena essential oil beginning at the 6th postoperative hour after cesarean delivery. For each session, 2 drops of Rosa damascena essential oil will be applied to a sterile gauze and held approximately 10 cm from the participant's nose. Participants will breathe normally during the inhalation period. The intervention will be performed at 6, 18, 30, and 42 hours after surgery, with each session lasting 10 minutes.

Aromatherapy Inhalation Group

Aromatherapy-Assisted Back Massage BEHAVIORAL

Participants will receive aromatherapy-assisted back massage beginning at the 6th postoperative hour after cesarean delivery. The massage will be applied to the upper and lower back regions using Rosa damascena essential oil diluted to 3% with sweet almond carrier oil. The intervention will be performed at 6, 18, 30, and 42 hours after surgery according to the study protocol. Participants will be positioned in a comfortable lateral or sitting position during the massage application.

Aromatherapy-Assisted Back Massage Group

placebo inhalation BEHAVIORAL

Participants will receive placebo inhalation using sterile water as a simulation of aromatherapy. The intervention will begin at the 6th postoperative hour after cesarean delivery and will be administered at 6, 18, 30, and 42 hours after surgery. Each session will follow the same procedure and duration as the aromatherapy inhalation group according to the study protocol.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Women aged 18-40 years Primiparous women Undergoing cesarean delivery under spinal anesthesia Term pregnancy (38-42 gestational weeks) Able to communicate and complete study questionnaires Willing to participate and provide written informed consent No known allergy to essential oils Intact sense of smell

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Usak University Training and Research Hospital

Uşak, Uşak, 64200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Central Study Contacts

ŞEYMA ÇATALGÖL, Dr

CONTACT

+905549734720; seyma.catalgol@usak.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Participants will be randomly assigned to one of three parallel groups: aromatherapy inhalation, aromatherapy-assisted back massage, or placebo group. Outcomes will be compared between groups after the intervention period.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: February 23, 2026
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)