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IRCT20171013036747N4 IRCT 2025-08-04 Birjand University of Medical Sciences Comparing the effect of aromatherapy on sleep quality and insomnia severity in patients with breast cancer Comparison of the effect of aromatherapy with Citrus aurantium and chamomile extracts on sleep quality, insomnia severity in breast cancer patients undergoing chemotherapy 2025-08-21 anticipated 186 Recruiting https://irct.ir/trial/65833 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible patients will be enrolled in the study using the accessible method and randomly assigned to one of the aromatherapy with spring orange or aromatherapy with chamomile control groups using a block design. Each block contains numbers one to eight. Each patient is assigned one of the numbers one to eight. A letter is assigned to each group (M) to the aromatherapy with spring orange group, A to the aromatherapy with chamomile group, and C to the control group. A sequence is created for a sample size of 186 people. For the process of concealing the random allocation, 30 opaque envelopes and 186 cards will be prepared. Eight cards are placed inside each envelope in order. The number of blocks is written on each envelope. The name of the desired group is written on each card in order. Patients are assigned to one of the study groups based on the aforementioned letters. The random blocks were prepared by a statistical consultant. The process of randomly assigning patients to the study groups is performed by the researcher. To generate a random sequence, permuted block randomization was used, generating eight blocks for four groups. The random sequence was generated online via www.sealedenvolope.com, Blinding description: Participants, data analysts, outcome assessors, and the data and safety monitoring committee were not informed about the blinding procedure. N/A Condition 1: Cancer. Condition 2: Sleep disorders. Intervention 1: Intervention group 1: Chamomile essential oil from Oil Darou Company; At 10 pm, the patient inhales 5 deep breaths for 10 minutes at equal intervals, and a handkerchief soaked in essential oil that will emit the scent for at least 8 hours is attached to the front of the patient's clothing at a distance of 10-15 cm from the nose. In this way, the patient is exposed to aromatherapy from 10 pm to 6 am, and aromatherapy is performed every night for 7 days with patient training and researcher supervision. According to previous training, 3 drops are applied to a cotton ball that will be prepared in advance as a necklace. The dropper then places the cotton ball 20-25 cm from the patient's head so that the patient can inhale it during sleep (for 8 hours) and removes it from the neck after waking up and throws it away. At the end of the intervention, the Petersburg Sleep Quality and Insomnia Severity Questionnaire is completed again by the patient and through an interview. Intervention 2: Intervention group 2: Spring orange essential oil from Oil Daru Company; At 10 pm, the patient inhales the essential oil by taking 5 deep breaths for 10 minutes at equal intervals, and a handkerchief soaked in the essential oil that will emit the aroma for at least 8 hours is attached to the front of the patient's clothes at a distance of 10-15 cm from the nose. In this way, the patient is exposed to aromatherapy from 10 pm to 6 am, and aromatherapy is performed every night for 7 days with patient training and researcher supervision. According to the previous training, 3 drops are placed on a cotton ball that will be prepared in advance as a necklace, the dropper then places the cotton ball at a distance of 20-25 cm from the patient's head so that he can inhale it during sleep (for 8 hours) and after waking up, he removes it from his neck and throws it away. At the end of the intervention, the Petersburg Sleep Quality and Insomnia Severity Questionnaire is completed again by the patient and through an interview. Intervention 3: Control group: Distilled water; At 10 pm, the intervention is inhaled by the patient by taking 5 deep breaths for 10 minutes at equal intervals, and a handkerchief soaked in essential oil that will emit the aroma for at least 8 hours is attached to the front of the patient's clothing at a distance of 10-15 cm from the nose. In this way, the patient is exposed to aromatherapy from 10 pm to 6 am, and aromatherapy is performed every night for 7 days with patient training and researcher supervision. According to the previous training, 3 drops are applied to a cotton ball that will be prepared in advance as a necklace, the dropper is then placed 20-25 cm from the patient's head so that the patient can inhale it during sleep (for 8 hours) and after waking up, the cotton ball is removed from the neck and thrown away. At the end of the intervention, the Petersburg Sleep Quality and Insomnia Severity Questionnaire is completed again by the patient and through an interview. Yes - There is a plan to make this available What will be shared: Only part of the information, such as information on the main outcome or the like, can be shared When: 10 months after printing results To whom: Researchers working in academia and academia Conditions: Just statistical tests Where to obtain: To receive the data, they can only send their application to the email address of the person responsible for the study E-mail:rasool.solaimani@yahoo.com How to obtain: After reviewing the ethics code of the respective research committee and the approval date and the university identification certificate of the applicant Comments:
public Rasool Solaimani Moghaddam
Ghaffari St
Birjand Iran (Islamic Republic of) 971785377 +98 56 3238 1200 Rasool.solaimani@yahoo.com Birjand University of Medical Sciences scientific Rasool Solaimani Moghadam
Ghaffari St
Birjand Iran (Islamic Republic of) 971785377 +98 56 3238 1200 rasool.solaimani@yahoo.com Birjand University of Medical Sciences Iran (Islamic Republic of) A lack of stressful events such as near-death or surgery in the last six months Age range from 18 to 60 years Having the consent to participate in the study Do not use the herbal remedy in the past month Not having allergic rhinitis, asthma, chronic pulmonary disease, sleep disorders and other chronic diseases that affect the sense of smell Lack of susceptibility to medicinal herbs Lack of sleeping pills Having breast cancer Patients undergoing chemotherapy (in the second to fourth cycles of chemotherapy) 18 years 65 years Female Occurrence of stressful events: close lives, divorces and ... during the study Use sleep Palliative interventions during the study Symptoms of allergy to the fragrance used Z85.8 G47 Personal history of malignant neoplasms of other organs and systems Sleep disorders Rehabilitation Rehabilitation Placebo Intervention group 1: Chamomile essential oil from Oil Darou Company; At 10 pm, the patient inhales 5 deep breaths for 10 minutes at equal intervals, and a handkerchief soaked in essential oil that will emit the scent for at least 8 hours is attached to the front of the patient's clothing at a distance of 10-15 cm from the nose. In this way, the patient is exposed to aromatherapy from 10 pm to 6 am, and aromatherapy is performed every night for 7 days with patient training and researcher supervision. According to previous training, 3 drops are applied to a cotton ball that will be prepared in advance as a necklace. The dropper then places the cotton ball 20-25 cm from the patient's head so that the patient can inhale it during sleep (for 8 hours) and removes it from the neck after waking up and throws it away. At the end of the intervention, the Petersburg Sleep Quality and Insomnia Severity Questionnaire is completed again by the patient and through an interview. Intervention group 2: Spring orange essential oil from Oil Daru Company; At 10 pm, the patient inhales the essential oil by taking 5 deep breaths for 10 minutes at equal intervals, and a handkerchief soaked in the essential oil that will emit the aroma for at least 8 hours is attached to the front of the patient's clothes at a distance of 10-15 cm from the nose. In this way, the patient is exposed to aromatherapy from 10 pm to 6 am, and aromatherapy is performed every night for 7 days with patient training and researcher supervision. According to the previous training, 3 drops are placed on a cotton ball that will be prepared in advance as a necklace, the dropper then places the cotton ball at a distance of 20-25 cm from the patient's head so that he can inhale it during sleep (for 8 hours) and after waking up, he removes it from his neck and throws it away. At the end of the intervention, the Petersburg Sleep Quality and Insomnia Severity Questionnaire is completed again by the patient and through an interview. Control group: Distilled water; At 10 pm, the intervention is inhaled by the patient by taking 5 deep breaths for 10 minutes at equal intervals, and a handkerchief soaked in essential oil that will emit the aroma for at least 8 hours is attached to the front of the patient's clothing at a distance of 10-15 cm from the nose. In this way, the patient is exposed to aromatherapy from 10 pm to 6 am, and aromatherapy is performed every night for 7 days with patient training and researcher supervision. According to the previous training, 3 drops are applied to a cotton ball that will be prepared in advance as a necklace, the dropper is then placed 20-25 cm from the patient's head so that the patient can inhale it during sleep (for 8 hours) and after waking up, the cotton ball is removed from the neck and thrown away. At the end of the intervention, the Petersburg Sleep Quality and Insomnia Severity Questionnaire is completed again by the patient and through an interview. Sleep quality. Timepoint: Before and 7 days after the intervention. Method of measurement: Standard sleep quality questionnaire Pittsburgh. Insomnia intensity. Timepoint: Before and 7 days after the intervention. Method of measurement: Standard sleep quality questionnaire Pittsburgh. Birjand University of Medical Sciences Approved 2022-10-22 Research Ethics Committees of Birjand University of Medical Sciences Birjand University of Medical Sciences , Ghafari Street, Birjand Birjand South Khorasan Iran (Islamic Republic of)