Aromatherapy and Massage After Cesarean Delivery: A Randomized Controlled Trial

Official title

Effects of Aromatherapy and Massage on Pain, Anxiety, and Comfort After Cesarean Delivery: A Randomized Controlled Trial

Overview

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.

Detailed description

Cesarean delivery is one of the most frequently performed surgical procedures worldwide and is commonly associated with postoperative pain, anxiety, and decreased maternal comfort during the early postpartum period. Effective management of these symptoms is important for maternal recovery, early mobilization, breastfeeding, and overall postpartum well-being.

Pharmacological approaches are commonly used for postoperative symptom management; however, interest in complementary non-pharmacological interventions has increased due to their potential supportive effects and ease of application. Aromatherapy and massage are among the approaches used to promote relaxation, reduce perceived discomfort, and improve psychological well-being.

This randomized controlled trial was designed to investigate the effects of aromatherapy-based interventions on postoperative recovery outcomes among women after cesarean delivery. The study compares aromatherapy inhalation, aromatherapy-assisted massage, and placebo conditions to evaluate their potential effects on maternal pain, anxiety, and comfort during the early postoperative period.

The results of this study may contribute to the evidence regarding the use of complementary supportive interventions in postpartum care following cesarean delivery.

Interventions

• Behavioral Aromatherapy Inhalation
  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.
• Behavioral Aromatherapy-Assisted Back Massage
  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.
• Behavioral placebo inhalation
  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.

Primary outcome measures

• Postoperative pain intensity [Time frame: From 6 to 42 hours after cesarean delivery (before and after each intervention session)]

Secondary outcome measures (2)

• Anxiety level [Time frame: Before the first intervention session and after the final intervention session (42 hours after cesarean delivery).]
• Postpartum comfort level [Time frame: Before the first intervention session and after the final intervention session (42 hours after cesarean delivery).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Usak University Training and Research Hospital — Uşak

Identifiers

NCT: NCT07743736 · 958-958-26

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗