NCT04324216

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

March 24, 2020

Last Update Submit

April 7, 2026

Conditions

Keywords

3D VRAromatherapyolder adulthappinessstresssleep qualityexperience on meditationlife satisfaction

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Experimental group

EXPERIMENTAL

3D virtual reality and hands-on aromatherapy

Other: 3D virtual reality and hands-on aromatherapy

Control group

NO INTERVENTION

No intervention

Interventions

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.

Experimental group

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • An ability to understand verbal instructions
  • An ability to provide simple responses
  • An ability to operate a joystick freely with at least one hand

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Normal University

Taipei, Taiwan

Location

Related Publications (24)

  • 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.

    PMID: 18266847BACKGROUND
  • 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. doi: 10.1053/apnu.2001.27020.

    PMID: 11584352BACKGROUND
  • 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. doi: 10.1016/j.physbeh.2005.06.031.

    PMID: 16095639BACKGROUND
  • 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. doi: 10.1089/1075553041323696.

    PMID: 15253846BACKGROUND
  • 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. Korean.

    PMID: 27857006BACKGROUND
  • 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.

    PMID: 25114901BACKGROUND
  • 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. Korean.

    PMID: 31932562BACKGROUND
  • 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. No abstract available.

    PMID: 26001720BACKGROUND
  • 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.

    PMID: 26051575BACKGROUND
  • 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.

    PMID: 18442859BACKGROUND
  • 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.

    PMID: 27168052BACKGROUND
  • 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.

    PMID: 25584799BACKGROUND
  • 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.

    PMID: 30202763BACKGROUND
  • 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. doi: 10.4040/jkan.2008.38.4.493. Korean.

    PMID: 18753801BACKGROUND
  • 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. doi: 10.1200/JCO.2006.08.9987.

    PMID: 17290062BACKGROUND
  • Tiran D, Chummun H. Complementary therapies to reduce physiological stress in pregnancy. Complement Ther Nurs Midwifery. 2004 Aug;10(3):162-7. doi: 10.1016/j.ctnm.2004.03.006.

    PMID: 15279857BACKGROUND
  • 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. doi: 10.1016/j.psychres.2005.12.012. Epub 2007 Feb 7.

    PMID: 17291597BACKGROUND
  • 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.

    PMID: 18172401BACKGROUND
  • 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.

    PMID: 22612017BACKGROUND
  • 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.

    PMID: 30057040BACKGROUND
  • 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. doi: 10.4040/jkan.2005.35.1.186. Korean.

    PMID: 15778570BACKGROUND
  • 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. doi: 10.1191/0269216304pm874oa.

    PMID: 15046404BACKGROUND
  • 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;2016(6):CD009873. doi: 10.1002/14651858.CD009873.pub3.

    PMID: 27258432BACKGROUND
  • Cheng VY, Huang CM, Liao JY, Hsu HP, Wang SW, Huang SF, Guo JL. Combination of 3-Dimensional Virtual Reality and Hands-On Aromatherapy in Improving Institutionalized Older Adults' Psychological Health: Quasi-Experimental Study. J Med Internet Res. 2020 Jul 23;22(7):e17096. doi: 10.2196/17096.

MeSH Terms

Conditions

Psychological Well-BeingSleep Initiation and Maintenance DisordersPersonal Satisfaction

Condition Hierarchy (Ancestors)

BehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Jong-Long Guo

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 27, 2020

Study Start

April 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations