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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04324216
Other study ID # 201903HM012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date December 31, 2019

Study information

Verified date March 2020
Source National Taiwan Normal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A quasi-experimental trial was designed to evaluate the effectiveness of this combination in promoting happiness, perceived stress, sleep quality, experience on meditation, and life satisfaction among institutionalized older adults in Taiwan.


Description:

Background: In Taiwan, which has one of the most rapidly aging populations in the world, it is becoming increasingly critical to promote successful aging strategies that are effective, easily usable, and acceptable to institutionalized older adults. Although many practitioners and professionals have explored aromatherapy and identified its positive psychological benefits, the effectiveness of a combination of 3D virtual reality and hands-on aromatherapy remains unknown.

Objectives: A quasi-experimental trial was designed to evaluate the effectiveness of this combination in promoting happiness, perceived stress, sleep quality, experience on meditation, and life satisfaction among institutionalized older adults in Taiwan.

Methods: Sixty institutionalized elderly participants underwent the combination program or were in a control group. Weekly two-hour sessions were implemented for 9 weeks. The outcome variables were happiness perceived, stress, sleep quality, experience on meditation, and life satisfaction, which were assessed at baseline, and after the intervention.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- An ability to understand verbal instructions

- An ability to provide simple responses

- An ability to operate a joystick freely with at least one hand

Exclusion Criteria:

- A history of severe psychiatric conditions;

- Dementia

- Significant visual or hearing impairment;

- Marked upper motor difficulties that could affect the participants' ability to participate in the study

- Currently suffering from severe illnesses, e.g., stroke and Parkinson disease.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
3D virtual reality and hands-on aromatherapy
Participants will receive 8-session 3DVR aroma therapy activities. Each session was delivered over 2 hours once a week, and at each session, the participant received hands-on guidance for preparing an aromatherapy product that they could use for the next seven days.

Locations

Country Name City State
Taiwan National Taiwan Normal University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan Normal University

Country where clinical trial is conducted

Taiwan, 

References & Publications (23)

Atsumi T, Tonosaki K. Smelling lavender and rosemary increases free radical scavenging activity and decreases cortisol level in saliva. Psychiatry Res. 2007 Feb 28;150(1):89-96. Epub 2007 Feb 7. — View Citation

Babakhanian M, Ghazanfarpour M, Kargarfard L, Roozbeh N, Darvish L, Khadivzadeh T, Dizavandi FR. Effect of Aromatherapy on the Treatment of Psychological Symptoms in Postmenopausal and Elderly Women: A Systematic Review and Meta-analysis. J Menopausal Med. 2018 Aug;24(2):127-132. doi: 10.6118/jmm.2018.24.2.127. Epub 2018 Aug 31. — View Citation

Bouya S, Ahmadidarehsima S, Badakhsh M, Balouchi A, Koochakzai M. Effect of aromatherapy interventions on hemodialysis complications: A systematic review. Complement Ther Clin Pract. 2018 Aug;32:130-138. doi: 10.1016/j.ctcp.2018.06.008. Epub 2018 Jun 13. Review. — View Citation

Chang SY. [Effects of aroma hand massage on pain, state anxiety and depression in hospice patients with terminal cancer]. Taehan Kanho Hakhoe Chi. 2008 Aug;38(4):493-502. Korean. — View Citation

Gueldner SH, Loeb S, Morris D, Penrod J, Bramlett M, Johnston L, Schlotzhauer P. A comparison of life satisfaction and mood in nursing home residents and community-dwelling elders. Arch Psychiatr Nurs. 2001 Oct;15(5):232-40. — View Citation

Hsu MC, Creedy D, Moyle W, Venturato L, Tsay SL, Ouyang WC. Use of Complementary and Alternative Medicine among adult patients for depression in Taiwan. J Affect Disord. 2008 Dec;111(2-3):360-5. doi: 10.1016/j.jad.2008.03.010. Epub 2008 Apr 28. — View Citation

Hwang E, Shin S. The effects of aromatherapy on sleep improvement: a systematic literature review and meta-analysis. J Altern Complement Med. 2015 Feb;21(2):61-8. doi: 10.1089/acm.2014.0113. Epub 2015 Jan 13. Review. — View Citation

Kim ME, Jun JH, Hur MH. [Effects of Aromatherapy on Sleep Quality: A Systematic Review and Meta-Analysis]. J Korean Acad Nurs. 2019 Dec;49(6):655-676. doi: 10.4040/jkan.2019.49.6.655. Review. Korean. — View Citation

Kim MJ, Nam ES, Paik SI. [The effects of aromatherapy on pain, depression, and life satisfaction of arthritis patients]. Taehan Kanho Hakhoe Chi. 2005 Feb;35(1):186-94. Korean. — View Citation

Kim S, Song JA, Kim ME, Hur MH. [Effects of Aromatherapy on Menopausal Symptoms, Perceived Stress and Depression in Middle-aged Women: A Systematic Review]. J Korean Acad Nurs. 2016 Oct;46(5):619-629. doi: 10.4040/jkan.2016.46.5.619. Review. Korean. — View Citation

Lehrner J, Marwinski G, Lehr S, Johren P, Deecke L. Ambient odors of orange and lavender reduce anxiety and improve mood in a dental office. Physiol Behav. 2005 Sep 15;86(1-2):92-5. — View Citation

Lua PL, Salihah N, Mazlan N. Effects of inhaled ginger aromatherapy on chemotherapy-induced nausea and vomiting and health-related quality of life in women with breast cancer. Complement Ther Med. 2015 Jun;23(3):396-404. doi: 10.1016/j.ctim.2015.03.009. Epub 2015 Apr 21. — View Citation

Redstone L. Mindfulness meditation and aromatherapy to reduce stress and anxiety. Arch Psychiatr Nurs. 2015 Jun;29(3):192-3. doi: 10.1016/j.apnu.2015.03.001. Epub 2015 Mar 13. — View Citation

Sayorwan W, Siripornpanich V, Piriyapunyaporn T, Hongratanaworakit T, Kotchabhakdi N, Ruangrungsi N. The effects of lavender oil inhalation on emotional states, autonomic nervous system, and brain electrical activity. J Med Assoc Thai. 2012 Apr;95(4):598-606. — View Citation

Shin ES, Seo KH, Lee SH, Jang JE, Jung YM, Kim MJ, Yeon JY. Massage with or without aromatherapy for symptom relief in people with cancer. Cochrane Database Syst Rev. 2016 Jun 3;(6):CD009873. doi: 10.1002/14651858.CD009873.pub3. Review. — View Citation

Smith MC, Kyle L. Holistic foundations of aromatherapy for nursing. Holist Nurs Pract. 2008 Jan-Feb;22(1):3-9; quiz 10-1. doi: 10.1097/01.HNP.0000306321.03590.32. Review. — View Citation

Snow LA, Hovanec L, Brandt J. A controlled trial of aromatherapy for agitation in nursing home patients with dementia. J Altern Complement Med. 2004 Jun;10(3):431-7. — View Citation

Soden K, Vincent K, Craske S, Lucas C, Ashley S. A randomized controlled trial of aromatherapy massage in a hospice setting. Palliat Med. 2004 Mar;18(2):87-92. — View Citation

Tang SK, Tse MY. Aromatherapy: does it help to relieve pain, depression, anxiety, and stress in community-dwelling older persons? Biomed Res Int. 2014;2014:430195. doi: 10.1155/2014/430195. Epub 2014 Jul 13. — View Citation

Tiran D, Chummun H. Complementary therapies to reduce physiological stress in pregnancy. Complement Ther Nurs Midwifery. 2004 Aug;10(3):162-7. Review. — View Citation

Tsai YF, Wong TK, Ku YC. Self-care management of sleep disturbances and risk factors for poor sleep among older residents of Taiwanese nursing homes. J Clin Nurs. 2008 May;17(9):1219-26. doi: 10.1111/j.1365-2702.2007.02020.x. Epub 2008 Feb 11. — View Citation

Wilkinson SM, Love SB, Westcombe AM, Gambles MA, Burgess CC, Cargill A, Young T, Maher EJ, Ramirez AJ. Effectiveness of aromatherapy massage in the management of anxiety and depression in patients with cancer: a multicenter randomized controlled trial. J Clin Oncol. 2007 Feb 10;25(5):532-9. — View Citation

Yang YP, Lee FP, Chao HC, Hsu FY, Wang JJ. Comparing the Effects of Cognitive Stimulation, Reminiscence, and Aroma-Massage on Agitation and Depressive Mood in People With Dementia. J Am Med Dir Assoc. 2016 Aug 1;17(8):719-24. doi: 10.1016/j.jamda.2016.03.021. Epub 2016 May 7. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Happiness The Oxford Happiness Inventory (OHI) was used to measure happiness. The OHI consists of 29 items, Each item was scored on a Likert-type scale of 1-4, with higher scores indicating a higher level of happiness. nine weeks
Primary Perceived stress The Perceived Stress Scale (PSS-14) consists of 14 items. Each item was scored on a Likert-type scale that ranged from 0 (never) to four (very often). With higher scores indicating a higher level of stress. nine week
Primary Sleep quality The Pittsburgh sleep quality index (PSQI) was consists of 14 items. Each item was scored on a Likert-type scale that ranged from 1 to 4, with higher scores indicating a lower level of sleep quality. nine weeks
Primary Experience on meditation A shortened version of the 10-item Experience on meditation (EOM-EL). Each item was scored on a Likert-type scale of 1-5, with higher scores indicating a higher level of experience on meditation. nine weeks
Primary Life satisfaction This scale is a short-form version containing 10 items from the 20-item Life Satisfaction Index A (LSIA). The response options for scoring were 0 indicating "Disagree" and 1 indicating "Agree". The total raw scores ranged from 0 to 10, with higher scores indicating a higher level of life satisfaction. nine weeks
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