Effects of Aromatherapy with Essential Oils on Anxiety and Depression in Perioperative Patients with Pancreatic Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital

About this trial

The objective of this study is to investigate whether aromatherapy essential oils are effective in alleviating anxiety and depression in participants undergoing perioperative pancreatic cancer treatment. Researchers compared aromatherapy essential oils with a placebo (a substance that appears similar but contains no essential oils) to determine their efficacy in reducing anxiety and depression in these participants. Participants were required to undergo aromatherapy for 2 hours daily over a period of 15 days. Assessments of anxiety and depression were conducted one day before surgery, 14 days after surgery, and 42 days after surgery, with their scores recorded accordingly.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meet diagnostic criteria in Chinese Anti-Cancer Association Guidelines for pancreatic cancer

Age ≥18 years

Contraception required, non-lactation period

Consistent with surgical indications

Disqualifiers

History of mental illness or cognitive impairment

Severe liver/kidney disease, cardiopulmonary dysfunction, tumor recurrence/metastasis

Allergy or intolerance to aromatic reagents, olfactory disorders, acute respiratory disease, serious complications (unstable vital signs, blood clotting disorders, irreversible metabolic diseases)

Poor compliance with study protocol or participation in similar studies

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental: Aromatherapy with essential oil intervention

    Other intervention

    Aromatherapy, customized to meet the psychological needs of pancreatic cancer patients, was employed as part of the intervention. A senior aromatherapist developed the protocol, selecting pleasant essential oils diluted at a ratio of 1-2 drops in 70ml of water. The aromatherapy was administered twice daily for one hour each session using an aromatherapy diffuser.During aromatherapy, nurses should inspect patients every 30 minutes to ensure comfort, and take immediate action if discomfort is reported.

  • Control Group 0.9% Isotonic Saline

    Other intervention

    1\. Pre - operation: Present pancreatic cancer knowledge, such as causes, common symptoms, treatment methods, and the need for surgery. Answer patients' queries promptly to reduce their fear of the disease and surgery. 2. Post - operation: Report the surgical outcome, explain common post - op complications and solutions to relieve negative emotions. 3. Post - operation: Intensify post - op education on drainage tube care, activity guidelines, disease knowledge, and diet advice. Strengthen mental health education, encourage family members to show more concern for patients, and enhance family support. 4. Pre - discharge: Provide discharge instructions to patients and their families. Guide patients who need tube removal and suture removal after discharge to make online appointments for outpatient follow - up.

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Aromatherapy with essential oil interventionExperimental treatment 1 intervention
Group B: control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Self-rating Anxiety Scale (SAS)

Zung\[20\] self-rating Anxiety Scale was adopted, which was compiled in 1971, with a total of 20 items, and scored according to the four levels of "no or occasionally (1 point)","sometimes (2 points)", "often (3 points)" and"always (4 points) ", in which items 5, 9, 13, 17 and 19 were scored in reverse. Add the scores of all items, multiply by the coefficient 1.25, and take their integer parts and remember them to the standard score. After the Chinese revision of the scale in China, the norm results are judged as follows: SAS standard score \<50 is no anxiety, 50 \~ 59 is mild anxiety, 60 \~69 is moderate anxiety, ≥70 is severe anxiety, the higher the score, the more serious the anxiety. Cronbach's a coefficient of the scale was 0.799, indicating good reliability and validity.

Time frame
Within 24 hours on the day of admission, after intervention (14 days after surgery) and 28 days after intervention (42 days after surgery).
2

Self-rating Depression Scale (SDS)

The Zung\[21\] Self-rating Depression Scale, which was developed in 1965, was used to assess the subjective feelings of individuals with depressive symptoms. There are 20 items that are scored on a 4-point scale based on the frequency of symptoms, where "1" means no or occasionally, "2" means sometimes, "3" means often, and "4" means always. Items 2, 5, 6, 11, 12, 14, 16, 17, 18, and20 are negative scoring questions, which are calculated as 4 to 1 points. Add the scores of all items, multiply by the coefficient1.25, and take their integer parts and remember them to the standard score. A standard score of \<53 indicates no depression, a score of 53-62 indicates mild depression, a score of 63-72 indicates moderate depression, a score of ≥73 indicates severe depression, and the higher the score, the more severe the depression. Cronbach's a coefficient of this scale was 0.78, indicating good reliability and validity.

Time frame
Within 24 hours on the day of admission, after intervention (14 days after surgery) and 28 days after intervention (42 days after surgery).

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

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