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

NCT06833658 | Not Yet Recruiting DMC

• 1 other identifier: 2023yan540-002
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pancreatic Carcinoma

Keywords

Aromatherapy with essential oil intervention; pancreatic carcinoma; Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Study Arms (2)

Aromatherapy with essential oil intervention

EXPERIMENTAL

The 15-day intervention commenced one day prior to surgery and concluded on the 13th post-operative day. Psychological support was delivered through bedside face-to-face interviews with patients. 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. Prior to surgery, patients complete anxiety and depression self-assessment scales on the 14th and 42nd days post-operation. If discharged early, a telephone follow-up with a nurse on the 42nd day is conducted to complete the assessment.

Other: Experimental: Aromatherapy with essential oil intervention

control group

PLACEBO COMPARATOR

The control group offers high - quality and personalized nursing care to patients in line with the "High - quality Nursing Service" principles. The care details are as follows: 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.

Other: Control Group 0.9% Isotonic Saline

Interventions

Experimental: Aromatherapy with essential oil intervention OTHER

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.

Also known as: Essential oil aromatherapy

Aromatherapy with essential oil intervention

Control Group 0.9% Isotonic Saline OTHER

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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet diagnostic criteria in Chinese Anti-Cancer Association Guidelines for pancreatic cancer
• Age ≥18 years
• Contraception required, non-lactation period
• Consistent with surgical indications
• Surgical procedures: pancreaticoduodenectomy, extended pancreaticoduodenectomy, costocaudectomy, total pancreatectomy, subtotal pancreatectomy, pyloric-sparing pancreaticoduodenectomy
• Elective surgery without preoperative radiotherapy or chemotherapy
• Normal communication
• Preoperative SAS score ≥50 or SDS score ≥53
• Informed consent from subject or guardian

You may not qualify if:

• 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
• Termination due to disease treatment or condition changes
• Withdrawal for personal reasons
• Deemed unsuitable by investigator.

Sponsors & Collaborators

• Peking University First Hospital: lead

MeSH Terms

Conditions

Pancreatic Neoplasms; Anxiety Disorders; Depression

Interventions

Control Groups; Sodium Chloride

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Xiaoyi X Liu Xiaoyi, 本科

CONTACT

8683572410; 768449859@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients should complete the self-rating Anxiety Scale (SAS) and Self-rating Depression Scale (SDS) within 24 hours on the day of admission. If the preoperative SAS score is ≥50 or (and)SDS score is ≥53, they can participate in this project, and then you need to sign the informed consent. According to the inclusion and exclusion criteria and admission to ward 1 and Ward 2, they were divided into test group and control group. The general information questionnaire was completed within 24 hours on the day of admission. Patients in ward 2 were given routine treatment, and patients in ward 1 selected several essential oils, diluted with tap water and scented with an aromatherapy machine, 1h each time, once in the afternoon. The intervention lasted a total of 15 days.

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: February 19, 2025
• Study Start: November 1, 2025
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share