The Effect of Foot Bath and Lavender Oil Sniffing on the Severity of Insomnia in Cancer Patients

NCT05288244 | Unknown

• 1 other identifier: EO-F-SAHIN-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Insomnia is observed due to the cancer itself, the treatments applied and the complaints experienced. Insomnia disrupts comfort and reduces the quality of life. This work; It is planned to evaluate the effect of foot bath and lavender oil scent applied for 14 days on the severity of insomnia. Within the scope of the study, the participants will be divided into three groups and the procedures will be applied. In the first group, between 21:00 - 21:20, you will be asked to place your feet in the foot bath apparatus with 38-40 ° C warm water. In the second group, between 21:00 and 21:05, a cotton pad with three drops of pure lavender oil will be fixed on the clothes in the upper chest and shoulder area, and you will be able to smell it for 5 minutes. The third group will be given both a foot bath and a scent of lavender oil.Which group the patients will fall into will be determined randomly. Research hypotheses: H0-1: Foot bath has no effect on the severity of insomnia in cancer patients. H1-1: Foot bath has an effect on the severity of insomnia in cancer patients H0-2: Smelling lavender oil has no effect on the severity of insomnia in cancer patients. H1-2: Smelling lavender oil has an effect on the severity of insomnia in cancer patients. H2: The effect of foot bath and lavender oil scenting applied together on the severity of insomnia in cancer patients is more than the application of only foot bath. H3: Foot bath and lavender oil sniffing applied together has a greater effect on the severity of insomnia in cancer patients than only lavender oil sniffing.

Conditions

Cancer Patient

Outcome Measures

Primary Outcomes (1)

• The effect of foot bath and lavender oil scent on insomnia severity in cancer patients

  Insomnia severity index and MD Anderson Symptom Index will be used to determine the severity of insomnia of the patients. Insomnia Severity Index consists of 7 questions. Scoring ranges from 0 to 28. While 28 points is the upper limit, it indicates that the patient has severe insomnia, while a lower score of 0 indicates that the patient does not have insomnia. The MD Anderson Symptom Index, on the other hand, is a scale used to evaluate the symptoms of the patient, consisting of a total of 19 questions. Although each question parameter is scored between 0 and 10, a score of 0 indicates that the patient has no symptoms, while the upper limit of 10 points indicates that the patient has severe symptoms.

  first day

Secondary Outcomes (1)

• The effect of foot bath and lavender oil scent on insomnia severity in cancer patients

  fiveteen day

Study Arms (3)

foot bath

EXPERIMENTAL

It will be applied to the patients in group A (foot bath) every evening between 21.00-21.20 for 14 days. The steps of the procedure are as follows: * To be used in the footbath, a footbath tub, water at 38-40°C, a thermometer to measure the temperature of the water, foot towels, clean socks, gloves are prepared. * With the water temperature adjustment button in the foot bath tub, wait until the temperature of the water reaches 38-40 °C * Between 21:00 and 21:20, the feet are kept in water with a constant temperature of 38-40 °C for 20 minutes. (While the process is in progress, the water temperature is checked intermittently with a laser thermometer.)

Other: To evaluate the effect of foot bath applied for 2 weeks on insomnia in cancer patients.

lavender oil snuff

EXPERIMENTAL

The L group (lavender oil sniffing) will be applied, the lavender oil sniffing process will be applied every evening between 21.00-21.05 for 14 days, and the process steps will be as follows; * Essential lavender oil to be used for the enterprise is obtained from a company that has business registration and TS EN ISO 9001: 2008 quality certificates with the number G06-3231 from the Ministry of Food, Agriculture and Livestock. * 3 drops of the obtained lavender oil are dripped onto the cotton pad. * The prepared cotton pad is fixed on the patient's clothing in the upper chest and shoulder area with a locked needle and the patient is asked to sniff for 5 minutes (Özkaraman et al., 2018).

Other: To evaluate the effectiveness of smelling lavender oil applied to cancer patients for 2 weeks on sleep.

foot bath and lavender oil snuff

EXPERIMENTAL

AL group (both foot bath and lavender oil sniffing),for 14 days, every evening between 21.00-21.20, foot bath and lavender oil sniffing between 21.00-21.05 will be applied together.

Other: To evaluate the effect of foot bath and lavender oil applied for 2 weeks on insomnia in cancer patients.

Interventions

To evaluate the effect of foot bath applied for 2 weeks on insomnia in cancer patients. OTHER

To evaluate the effect of foot bath applied for 2 weeks on insomnia in cancer patients.

foot bath

To evaluate the effectiveness of smelling lavender oil applied to cancer patients for 2 weeks on sleep. OTHER

To evaluate the effectiveness of smelling lavender oil applied to cancer patients for 2 weeks on sleep.

lavender oil snuff

To evaluate the effect of foot bath and lavender oil applied for 2 weeks on insomnia in cancer patients. OTHER

To evaluate the effect of foot bath and lavender oil applied for 2 weeks on insomnia in cancer patients.

foot bath and lavender oil snuff

Eligibility Criteria

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

You may qualify if:

• over 18 years old,
• Diagnosed with cancer,
• Having a sense of smell,
• Foot skin integrity is complete,
• Conscious,
• Patients who agreed to participate in the study

You may not qualify if:

• with peripheral vascular disease,
• with asthma,
• Known allergy history
• Before the procedure, using products such as antiperspirants, perfumes, sprays that contain any odor on their hair and body,
• Cancer patients receiving drug therapy for insomnia

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir City Hospital

Eskişehir, 38000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• -Lee, K., Cho, M., Miaskowski, C., Dodd, M. Impaired sleep and rhythms in persons with cancer. Sleep Med Rev;2004;8(3):199-212. CrossRef -Hagar, F.S. Effect of warm water foot bath on fatigue in patients undergoing hemodialysis. International Journal of Nursing Didactics,2018; 8, 26-32. -Yang, H.-L., et al. The effects of warm-water footbath on relieving fatigue and insomnia of the gynecologic cancer patients on chemotherapy. Cancer nursing,2010; 33(6): 454-460. -Yamamoto, K., Nagata,S. Physiological and psychological evaluation of the wrapped warm footbath as a complementary nursing therapy to induce relaxation in hospitalized patients with incurable cancer: a pilot study. Cancer nursing, 2011;34(3): 185-192. -Harada, T., Iwakawa, Y., Ikeda, H.Thermographic study on the preservability of heat effects of footbath with salt. Hiroshima J Med Sci, 2014;63(1-3): 1-5. -Seyyedrasooli, A., Valizadeh, L., Zamanzadeh, V., Nasiri, K., Kalantri, H. The effect of footbath on sleep quality of the elderly: A blinded randomized clinical trial. Journal of Caring Sciences, 2013; 2(4): 305-311 -Bensouilah, J. The history and development of modern-British aromatherapy. International Journal of Aromatherapy,2005; 15(3), 134-140. -Keville, K., Green, M. (2009). Aromatherapy: A Complete Guide to the Healing Art (2nd ed.). New York: Crossing Press.

  RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: randomization controlled study

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 21, 2022
• Study Start: August 13, 2021
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)