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NCT Number: NCT05464602

The Effect of Aromatherapy in Laparoscopic Cholecystectomy Patients

Pain experienced before and after surgery in patients undergoing laparoscopic cholecystectomy adversely affects physiological parameters and sleep quality. This randomized controlled study was conducted to examine the effects of preoperative and postoperative inhalation lavender and geranium essential oil on patients undergoing laparoscopic cholecystectomy on pain, sleep, and physiological parameters. The study was completed with 3 groups and 150 people, namely the geranium oil group (n=50), lavender oil group (n=50) and control group (n=50). The ethics committee approval, informed consent of the individuals and the institutional permission were obtained. In the study, data were collected using the patient identification form, Richard-Campbell Sleep Scale and visual analog scale. Chi-square test,repeated measures one-way analysis of variance, and Spearman correlation analysis tests were used to assess the data. In the comparisons, the value of p<0.05 was accepted as significant.

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Key information

Conditions

Cholecystectomy Aromatherapy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Kayseri, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥18 years
  • Hospitalized for laparoscopic cholecystectomy surgery,
  • Alzheimer's, dementia etc. no disease,
  • Having no perception problems (sense of smell, vision, hearing loss),
  • Hospitalized the day before the operation,
  • Patients who continue to stay in the hospital for at least one night after the operation will be included in the study.

Exclusion criteria

  • Having any respiratory system disease (COPD, Asthma, etc.),
  • Disturbed by the smell of essential oils,
  • Any allergic diagnosis and history,
  • Using anxiolytic, antidepressant,

Treatment and study plan

Intervention group Lavender

Other

This group received inhalation aromatherapy 2 drops of lavender oil from aromastone for a total of 3 days, one day before the operation, the day of the operation and the first day after the operation.

Other names: Lavender oil

Intervention group Geranium

Other

This group received inhalation aromatherapy 2 drops of geranium oil from aromastone for a total of 3 days, one day before the operation, the day of the operation and the first day after the operation.

Other names: Geranium oil

Primary outcomes

  1. Visual Analog Scale

    Time frame: change from baseline score at the end of three day

    The range of 0 (zero) and 10cm is determined on a ruler. 0 (zero) means "no pain" and 10 means "worst possible pain". The patient is asked to mark the place that expresses the pain on the line. The distance marked by the patient is measured by taking the initial distance of zero.

Secondary outcomes

  1. The Richards-Campbell Sleep Questionnaire

    Time frame: change from baseline score at the end of three day

    The Richard Campbell Sleep Questionnaire is a 6-item scale that evaluates the depth of sleep, the time to fall asleep, the frequency of awakening, the time to stay awake, the quality of sleep, and the noise level in the environment. Each item is evaluated on a chart with scores between 0 and 100. If the total mean score obtained from the scale is between "0-25", it indicates very bad sleep, between "26-75" indicates moderate sleep, and between "76-100" indicates very good sleep. The higher the score obtained from the scale, the higher the sleep quality of the patient is considered.

Other outcomes

  1. Physiological parameter (Blood Pressure)

    Time frame: change from baseline score at the end of three day

    The systolic and diastolic blood pressures of the patients were recorded by the researchers the day before, the day of surgery, and the day after surgery.

  2. Physiological parameter(Heart rate)

    Time frame: change from baseline score at the end of three day

    The heart rate of the patients was recorded by the researchers the day before the surgery, the day of the surgery, and the day after the surgery.

  3. Physiological parameter(Respiratory rate)

    Time frame: change from baseline score at the end of three day

    The respiratory rate of the patients was recorded by the researchers the day before the surgery, the day of the surgery, and the day after the surgery.

  4. Physiological parameter(SPO2)

    Time frame: change from baseline score at the end of three day

    The SPO2 of the patients was recorded by the researchers the day before the surgery, the day of the surgery, and the day after the surgery.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

The Effect of Aromatherapy on Postoperative Pain, Sleep Quality and Physiological Parameters in Laparoscopic Cholecystectomy Patients

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2022
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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