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2025-11-01
2025-12-03
2025-12-03
156
NCT06833658
Peking University First Hospital
Peking University First Hospital
INTERVENTIONAL
Effects of Aromatherapy with Essential Oils on Anxiety and Depression in Perioperative Patients with Pancreatic Cancer
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.
Female participants in this study must not be pregnant or breastfeeding during the project period. Although the essential oils used in aromatherapy have minimal effects on infants, there remains a slight risk of developmental issues. Therefore, participants are required to use contraception. If pregnancy occurs or is suspected during the study period, the participant must immediately notify the researcher to terminate their participation and receive further guidance. Male participants are also required to use contraception.Participation in this study is entirely voluntary and free of charge. You may choose not to participate or withdraw at any time, and this will not have any adverse effects on your medical care. If you decide to withdraw, please promptly inform your study physician to obtain relevant health advice. We will also promptly inform you of any significant information that may affect your decision to participate.Regulatory authorities may decide to terminate the study during the research period. If the study is concluded prematurely, we will notify you immediately, and your study physician will provide recommendations for subsequent treatment based on your health condition. If you choose to withdraw from the study midway, we will offer a final follow-up, but you have the option not to participate. After withdrawing from the study, if there is new information concerning your health and rights, we may contact you. Following your withdrawal, your information will be kept strictly confidential until its destruction and will not be further used or disclosed. However, in certain exceptional circumstances, even after your withdrawal or the conclusion of the study, researchers may still use or disclose your information.Unless it affects the scientific integrity of the research or the evaluation of data security, your information will not be disclosed; only information necessary for research, teaching, and other related activities will be provided, excluding personal identification details such as names and ID numbers. If required by government regulatory authorities, all research information, including your participation details, will be provided.If participation in this study results in any health impairment, please contact the researchers (Liu Xiaoyi, 83572652) immediately. We will promptly provide necessary medical treatment and offer compensation in accordance with national legal regulations.Your personal information and participation in this study will be strictly confidential and will not be disclosed to anyone outside the research team without authorization. All researchers are obligated to protect your privacy. Your data will be stored in a locked file cabinet and will only be accessible to authorized researchers. To ensure compliance with research regulations, government or ethics committee members may need to review your information. When the research results are published, your personal data will not be disclosed.If you have any questions regarding the rights and interests of the participants, you may contact the Biomedical Research Ethics Committee of Peking University First Hospital at the following telephone number: 010-66119025. Informed Consent Signature Page Subject's Informed Consent Statement The researcher has explained to me the background, purpose, procedures, risks, and benefits of the study titled "The Effect of Aromatherapy Essential Oils on Anxiety and Depression in Perioperative Pancreatic Cancer Participants." I have had sufficient time and opportunity to ask questions, and I am satisfied with the answers provided by the researcher. I know whom to contact if I have further questions or need additional information. I have read this informed consent form and decided to participate in this study. I understand that I may withdraw from this study at any time during the research period without providing any reason. I have been informed that I will receive a copy of this informed consent form, which includes both my signature and the researcher's signature. Subject's Signature: ___________________________ Date: _______________ Researcher's Declaration I have explained to the subject the background, purpose, procedures, risks, and benefits of the study titled "The Effect of Aromatherapy Essential Oils on Anxiety and Depression in Perioperative Pancreatic Cancer Participants." I have provided sufficient time for the subject to read the informed consent form, discuss it with others, and have answered all questions regarding the study. I have informed the subject of the contact information for any research-related inquiries. I have also informed the subject that they may withdraw from the study at any time without providing any reason. Researcher's Signature: ___________________________ Date: _______________
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-12-12 | N/A | 2025-02-18 |
2025-02-18 | N/A | 2025-02-19 |
2025-02-19 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Aromatherapy with essential oil intervention 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 | OTHER: Experimental: Aromatherapy with essential oil intervention
|
| PLACEBO_COMPARATOR: control group 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, comm | OTHER: Control Group 0.9% Isotonic Saline
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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). |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Xiaoyi X Liu Xiaoyi, 本科 Phone Number: 8683572410 Email: 768449859@qq.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
