Effect of Aromatherapy on Perioperative Anxiety Level in Cesarean Sections

NCT05334537 | Completed

• 1 other identifier: 2020/05-14
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia has been accepted as the first choice for elective cesarean section due to its easy application technique and elimination of the risks of difficult intubation and aspiration. Neuraxial anesthesia is considered superior to general anesthesia in terms of fetal well-being. The state of having an operation and not being aware of the operation by the patient can cause serious anxiety and fear in the patient. Fear of surgical failure, not fully understanding the anesthesia method, possible risks of anesthesia and expected pain during the postoperative recovery period contribute to the patient's anxiety. Considering the patients undergoing elective surgery under spinal anesthesia, there is a moderate level of anxiety associated with advanced age and female gender. Reducing the stress and anxiety in the patient during elective surgery will reduce the neurohormonal response to surgery and reduce complications. Early skin-to-skin contact with the mother provides many benefits to the newborn, but maternal sedation in the operating room during cesarean delivery should also be within safe limits to avoid early skin-to-skin contact. Aromatherapy relies on the use of essential oils to contribute to physical and psychological well-being. The oils can be massaged into the skin, or inhaled using a steam infusion or burner. Birth pain is a severe pain, and the feeling of pain may increase with tension, fear and anxiety during delivery. Apart from medical methods, many complementary treatments such as acupuncture, reflexology, homeopathy, hypnotherapy, music and aromatherapy are tried to reduce pain and anxiety. Lavender aromatherapy has been shown to significantly reduce anxiety or pain in various surgical procedures. There is a growing literature on the use of lavender aromatherapy as an anxiolytic agent. Based on these findings, the study aimed to contribute to early mother-to-baby contact and breast milk intake by reducing perioperative maternal anxiety and therefore the use of sedative drugs during cesarean section performed under spinal anesthesia with the intraoperative use of lavender aromatherapy. This is the first study to evaluate the effect of aromatherapy on anxiety in cases of cesarean section under anesthesia.

Conditions

Anxiety; Midazolam Overdose; Breast Feeding

Keywords

aromatherapy; lavandula; sedative; spinal anesthesia; Anxiety

Outcome Measures

Primary Outcomes (2)

• Comparison between patients using aromatherapy and those without aromatherapy

  A comparison will be made between the two groups, one group using lavender aromatherapy and one group without aromatherapy. T-tests used to assess whether the two groups are statistically different from each other. Comparisons made by comparing with the midazolam consumption. After 5 minutes from baby's birth, 2 mg intravenous midazolam for sedation was administred to the patients who gained 1 point from the Ramsey Sedation Scale. It is a six category scale that allows the evaluation of the sedation level and was created by Ramsey et al. (score 1: anxious, agitated and restless; score 2: cooperative, oriented and tranquil; score 3: responsive to commands only; score 4: brisk response to a light glabellar tap; score 5: sluggish response to a light glabellar tap or loud auditory stimulus; score 6: means no response).

  Within one hour following the cesarean section

• Comparison between patients using aromatherapy and those without aromatherapy

  Comparison between two groups for the postoperative 3rd hour STAI-I scores. Ensuring the baby's clean breast milk intake and early mother-infant skin contact

  Postoperative 3rd hour

Study Arms (2)

the aromatherapy group

EXPERIMENTAL

After the birth of the baby, two drops of 100% pure medical lavender oil (Lavandula angustifolia) was inhaled for 5 min through an oxygen mask by groups A and C, respectively. After 5 min, 2 mg intravenous midazolam for sedation was administred to the patients who gained 1 point from the Ramsey Sedation Scale (RSS). Complications, such as nausea, vomiting, hypotension (mean arterial pressure\<60 mmHg), and allergies that developed after aromatherapy, were recorded. At the end of the operation, the dose added to the initial midazolam dose for all patients and the total surgical time were recorded. VAS pain and STAI-I scores were re-evaluated at the third postoperative hour, and the satisfaction levels of each patient after aromatherapy were recorded according to the Likert scale as "very satisfied, satisfied, moderate, and not at all satisfied".

Other: Aromatherapy

the control group

PLACEBO COMPARATOR

Then, after the birth of the baby two drops of odorless baby oil (jojoba and almond oil) was inhaled for 5 min through an oxygen mask by groups A and C, respectively. After 5 min, 2 mg intravenous midazolam for sedation was administred to the patients who gained 1 point from the Ramsey Sedation Scale (RSS). Complications, such as nausea, vomiting, hypotension (mean arterial pressure\<60 mmHg), and allergies that developed after aromatherapy, were recorded. At the end of the operation, the dose added to the initial midazolam dose for all patients and the total surgical time were recorded. VAS pain and STAI-I scores were re-evaluated at the third postoperative hour, and the satisfaction levels of each patient after aromatherapy were recorded according to the Likert scale as "very satisfied, satisfied, moderate, and not at all satisfied".

Other: Placebo oil (odorless baby oil- jojoba and almond oil)

Interventions

Aromatherapy OTHER

Ninety-six patients aged between 18 and 45 years, with a height of ≥156 centimeters (cm), and a gestational age of \>37 weeks, in the ASA II risk group, who were scheduled for elective CS under spinal anesthesia, were included in the study. Patients who were to undergo lavender aromatherapy with an oxygen mask after the birth of the baby were randomly divided into two groups: aromatherapy (A) (n=48) and control (C) (n=48), who inhaled odorless essential oil. Participants were admitted to the preoperative preparation room 20 min before the operation, and their age, height, weight, and ASA risk scores were recorded after their informed consent was obtained. They were monitored and sent to the operating room after their baseline anxiety levels were measured and recorded using the Visual Analog Scale (VAS) for pain and State-Trait Anxiety Inventory (STAI-I).

the aromatherapy group

Placebo oil (odorless baby oil- jojoba and almond oil) OTHER

Ninety-six patients aged between 18 and 45 years, with a height of ≥156 centimeters (cm), and a gestational age of \>37 weeks, in the ASA II risk group, who were scheduled for elective CS under spinal anesthesia, were included in the study. Patients who were to undergo lavender aromatherapy with an oxygen mask after the birth of the baby were randomly divided into two groups: aromatherapy (A) (n=48) and control (C) (n=48), who inhaled odorless essential oil. Participants were admitted to the preoperative preparation room 20 min before the operation, and their age, height, weight, and ASA risk scores were recorded after their informed consent was obtained. They were monitored and sent to the operating room after their baseline anxiety levels were measured and recorded using the Visual Analog Scale (VAS) for pain and State-Trait Anxiety Inventory (STAI-I).

the control group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women who underwent CS with spinal anesthesia
• Ninety-six patients aged between 18 and 45 years,
• With a height of ≥156 centimeters (cm)
• Gestational age of \>37 weeks
• The American Society of Anesthesiologists (ASA) II risk group, who were scheduled for elective CS under spinal anesthesia

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

KahramanmarasSIU

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Breast Feeding

Interventions

Aromatherapy; almond oil

Condition Hierarchy (Ancestors)

Mental Disorders; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 19, 2022
• Study Start: June 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)