Clinical trial NCT06119282: The Effect of Aromatherapy in Women With Primiparous Cesarean Section
Official title: The Effect of Aromatherapy on Acute Pain Anxiety and Comfort Levels in Women With Primiparous Cesarean Section Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aromatherapy
Cesarean Section Complications
Primiparity
Postpartum Period
Keywords: Aromatherapy
Cesarean Section
Primiparity
Postpartum Period
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The research will be conducted as a randomized controlled intervention study to evaluate and compare the effects of massage and inhaler aromatherapy on acute pain, comfort level and anxiety in primiparous cesarean section women.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was organized as a randomized controlled trial. The sample was calculated as 120 (Control: 60, Experiment 1:30 Experiment 2:30). Primiparous cesarean section women will be evaluated for pain, postpartum comfort and anxiety levels by using lavender oil, tangerine oil and vetiver oil. The first group will be given inhaler application, the second group will be massage and aromatherapy application. The third group will be the control group.

Detailed description: 1. Essential Oils and Preparation Steps:

   Obstetrics and Gynecology Specialist, who has a Phytotherapy Certificate approved by the Ministry of Health, in the selection of essential oils, the creation and dilution of the essential mixture. Instructor Consultancy was received from its member Ayşe Şeyma Küçükakça.
2. Preparation of Essential Mixture:

   It should be preferred to use essential oils as a mixture rather than using them alone. The reason for this is to benefit from the synergy created by essential oils. While a mixture of 5 essential oils is preferred in general use, a maximum of 3 essential oils are used after delivery. Note system is used to create synergy between essential oils. The mixture is created by choosing 1 oil from the top note, middle note and bottom note oils. In the essential blend, the first to be smelled is the top note, the middle note is followed by the top note, and the last is the bottom note. The effect of the oils in the mixture is revealed by the heat, and the effect of the oils in the bottom note is revealed. While creating the essential mixture, essential oils with the same effect are preferred to support the desired effect, and top notes can be used to lighten the aroma of these two oils.

   Mandarin (Citrus Nobilis): Top note is citrus essential oil. It has antimicrobial, antiseptic, antispasmodic, anti-inflammatory, diuretic, sleep quality-enhancing, antidepressant, anxiety and stress relieving properties. There is no known side effects. However, exposure to sunlight should be avoided until 12 hours after the application. It can be used with 3%-50% dilution. It creates synergy with lavender and vetiver.

   Lavender (Lavandula Angustifolia): Middle note is a floral essential oil. Its effects are analgesic, supportive of skin health, antibacterial, anti-inflammatory, antiseptic, relaxant, antipyretic, improving sleep quality, balancing blood pressure, antidepressant, reducing stress, fear and anxiety, and helps panic attacks. There is no known side effects. It can be used in 5%-pure form. Vetiver creates synergy with Mandarin.

   Vetiver (Vetiveria zizanoides): Vetiver is woody essential oil from the base notes. Its effects are analgesic, antibacterial, antimicrobial, helping cell regeneration, antispasmodic, improving sleep quality, reducing anxiety and stress, increasing focus and concentration, antidepressant, helping anger control and helping to get rid of negative emotions such as fear. There is no known side effects. It can be used with 5%-50% dilution. It creates synergy with lavender and tangerine.

   Grape Seed Oil: It is a carrier oil suitable for all skin types. It is antiallergic. It has skin moisturizing properties. It is odorless, tasteless and easily absorbed. It has antioxidant properties. It contains high amount of vitamin E. It helps wound healing and cell regeneration. It has anti-inflammatory and calming properties.
3. Dilution of Essential Oils:

   Essential oils should be diluted with carrier oils. The dilution rate is recommen\*ded as 1% for children and 2% for adults. The base oil to be used in dilution is 1% dilution rate as 3 drops of essential oil per 5 ml of base oil. The essential oils to be used in the research will be applied by diluting 1% in order to be easy to tolerate and to reduce the possibility of reaction. 3 drops of tangerine, 2 drops of lavender and 1 drop of vetiver will be added to 10 ml of grape seed oil. As tangerine is the top note, its volatility is high. Therefore, 3 drops will be used. Lavender is the middle note essential oil and again volatile. 2 drops will be added to the essential mixture. Vetiver is a base oil. It is more permanent. Therefore, 1 drop will be used.
4. Inhaler Administration Guide:

   After the cesarean section, at the 8th hour postpartum, the VAS/GCA is evaluated, 4 drops of carrier oil are dropped on the upper and lower parts of the wick of the aroma stick, and then 15-20 drops of the prepared essential mixture are dropped and the woman is explained about its use. By the 8th hour of the postop, 4\*1 women are allowed to sniff. Before the application, the 30th and 60th minutes VAS/GOC, vital parameters are evaluated.
5. Massage Application Guide:

   When the studies conducted with the massage method are examined, back massage is applied for 10-30 minutes. Considering the working conditions of the institution, it is thought that a 10-minute massage may be sufficient for the application. The massage application is started at the postpartum 8th hour and applied for 10 minutes on the postoperative 0th day 1\*1, 2 times on the postoperative 1st and 2nd days when the woman feels ready. 30 and 60 minutes before application. then VAS/GCS, vital parameters are monitored.

   Before the Application; A room with an average temperature of 25 °C and far from noise is arranged for the massage. An examination table, chair or patient bed of appropriate width (60-65 cm) and height (70-80 cm) is used for the procedure.

   After the postpartum woman is brought to a comfortable position, she is given a side lying/inverted sitting position on the chair and the abdominal region is supported.

   The patient's clothing is removed from his shoulders to the sacral region, exposing his back. If the patient's body is damp and sweaty, it is wiped with a paper towel.

   Hands are washed and warmed by rubbing against each other. According to the patient's back area, 2-4 ml of essential oil, which has been approximately warmed by the bain-marie method, is taken into the palm of the hand and applied to the patient's back and massaged.

   Massage begins in the direction of the heart and by following the direction of the muscle fibers.
6. Control Group Follow-up Guide:

Pregnant women included in the control group will be left to clinical care, and pain and vital parameters will be monitored starting from the 8th postoperative hour. The scales applied to the experimental groups will be applied on the 2nd postoperative day. Women in the control group who completed the study will be informed about the postpartum use of aromatherapy. Women who want aromatherapy application will be directed to GETAT center.

Eligibility criteria: Inclusion Criteria

* Being able to speak, read and write Turkish,
* Agree to work with selected essential oils,
* Over 18 years of age and volunteering to participate in the study,
* Being nulliparous
* Not having a previous surgical operation history,
* Not to be a risky pregnancy (HT, Gestational diabetes, asthma, etc.),
* No emergency cesarean section complication (EDT, pregnant with bleeding, etc.),
* Not allergic to aromatherapy oils to be applied,
* Presence of sense of smell.

Exclusion Criteria:

* Wanting to stop working
* Complications during/after cesarean section,
* Being multiparous

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 2 days
measure: State-Trait Anxiety Inventory
timeFrame: 2 days
measure: Postpartum Comfort Questionnaire (PPCQ)
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
state: Fatih
Study officials:
affiliation: Istanbul University Cerrahpasa Florence Nightingale Faculty of Nursing
name: Gülnihal ARTUĞ CANSIZLAR, 1
role: PRINCIPAL_INVESTIGATOR
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