Mental HealthNCT04324216
Three-dimensional Virtual Reality and Hands-on Aromatherapy
A study testing 3D virtual reality and hands-on aromatherapy in people with Mental Health, run by National Taiwan Normal University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- 3D virtual reality and hands-on aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- An ability to understand verbal instructions
- An ability to provide simple responses
- An ability to operate a joystick freely with at least one hand
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Combination of Three-dimensional Virtual Reality and Hands-on Aromatherapy in Improving Institutionalized Older Adults' Psychological Health
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.
Read the detailed 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.
- Conditions
- Mental Health
- Being tested
- 3D virtual reality and hands-on aromatherapy
- Keywords
- 3D VR, Aromatherapy, older adult, happiness, stress, sleep quality, experience on meditation, life satisfaction
- Medical subject headings
- Psychological Well-Being, Sleep Initiation and Maintenance Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D virtual reality and hands-on aromatherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 3D virtual reality and hands-on aromatherapy Receives: Other: 3D virtual reality and hands-on aromatherapy |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: nine weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Apr 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong-Long Guo, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324216
- Sponsor's protocol ID
- 201903HM012
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2020
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18266847Gueldner 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.
PubMed 11584352Lehrner 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.
PubMed 16095639Snow 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.
PubMed 15253846Kim 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.
PubMed 27857006Tang 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.
PubMed 25114901Kim 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.
PubMed 31932562Redstone 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.
PubMed 26001720Lua 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.
PubMed 26051575Hsu 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.
PubMed 18442859Yang 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.
PubMed 27168052Hwang 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.
PubMed 25584799Babakhanian 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.
PubMed 30202763Chang 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.
PubMed 18753801Wilkinson 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.
PubMed 17290062
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combination of Three-dimensional Virtual Reality and Hands-on Aromatherapy in Improving Institutionalized Older Adults' Psychological Health
- ClinicalTrials.gov ID
- NCT04324216
- Acronym / sponsor ID
- 201903HM012
- Conditions
- Mental Health
- Keywords
- 3D VR, Aromatherapy, older adult, happiness, stress, sleep quality, experience on meditation, life satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: 3D virtual reality and hands-on aromatherapy3D virtual reality and hands-on aromatherapy |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- An ability to understand verbal instructions
- An ability to provide simple responses
- An ability to operate a joystick freely with at least one hand
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D virtual reality and hands-on aromatherapyParticipants 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. | Other | Experimental group |
Primary outcome
Happiness
Time frame: nine weeks
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.
Perceived stress
Time frame: nine week
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.
Sleep quality
Time frame: nine weeks
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.
Experience on meditation
Time frame: nine weeks
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.
Life satisfaction
Time frame: nine weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 18266847Tsai 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.
- Background: PubMed 11584352Gueldner 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.
- Background: PubMed 16095639Lehrner 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.
- Background: PubMed 15253846Snow 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.
- Background: PubMed 27857006Kim 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.
- Background: PubMed 25114901Tang 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.
- Background: PubMed 31932562Kim 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.
- Background: PubMed 26001720Redstone 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.
- Background: PubMed 26051575Lua 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.
- Background: PubMed 18442859Hsu 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.
- Background: PubMed 27168052Yang 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.
- Background: PubMed 25584799Hwang 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.
- Individual participant dataSharing planned: No
Related trials for Mental Health
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Enrolling by invitationObservational study
Bone-Lead Level Associations With Brain and Mental Health
Lead Exposure
Active, not recruiting
Improving Emotional Wellbeing of University Students: Emotion Regulation
Emotion Regulation
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
Active, not recruiting
Improving Emotional Wellbeing of University Students: Anxiety Management
Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Long Guo principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D virtual reality and hands-on aromatherapy in people with Mental Health, run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Happiness (time frame: nine weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324216, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.