Effects of Aromatherapy and Massage on Pain, Anxiety, and Comfort After Cesarean Delivery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Postoperative pain intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Aromatherapy Inhalation Group
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.
干预措施: Aromatherapy Inhalation (Behavioral)
Aromatherapy-Assisted Back Massage Group
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.
干预措施: Aromatherapy-Assisted Back Massage (Behavioral)
Placebo Group
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.
干预措施: placebo inhalation (Behavioral)
结局指标
主要结局
Postoperative pain intensity
时间窗: From 6 to 42 hours after cesarean delivery (before and after each intervention session)
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 0-10 scale in which higher scores indicate greater pain intensity.
次要结局
- 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).)
研究者
Şeyma Çatalgöl
Principal Investigator
Uşak University