Effects of Complementary Therapies Delivered Via Mobile Technologies
1 other identifier
interventional
105
1 country
1
Brief Summary
The purpose of this study is to determine the effects of complementary therapies delivered via mobile technologies have a therapeutic effect on surgical patients' anxiety, pain, and self-efficacy in healing reports before, following, and at 10-day follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 4, 2014
CompletedFirst Posted
Study publicly available on registry
September 10, 2014
CompletedSeptember 10, 2014
September 1, 2014
9 months
September 4, 2014
September 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline state anxiety via the State Trait Anxiety Scale (STAI)
A randomized controlled trial (RCT) involving 105 SDS patients, who were assigned to an ART (n = 25), MI (n = 25), NVAM (n = 15), NVA (n = 16), or a control group (n = 24) were assessed for state anxiety via the State Trait Anxiety Inventory (STAI), self-reported pain using the numeric rating scale (NRS), and self-efficacy with the general self- efficacy scale (GSE) four days prior to surgery, immediately prior and following the surgical intervention, and at day five post-operative.
Ten days
Secondary Outcomes (1)
Change in baseline pain level using the Numeric Rating Scale (NRS)
Ten Days
Other Outcomes (1)
Change in self-efficacy in healing using the General Self-Efficacy Scale (GSE)
Ten Days
Study Arms (4)
Audio Relaxation technique
EXPERIMENTALRelaxation is a process that decreases the effects of stress on your mind and body. Relaxation techniques can help you cope with everyday stress and with stress related to various health problems, such as cancer and pain.
Medical Music Intervention
EXPERIMENTALMusic intervention is use to assist with relaxation and reduce stress levels in patients.
Nature Therapy without Music
EXPERIMENTALEcotherapy is the use of nature to reduce stress and to increase levels of well-being in patients.
Nature Therapy with Music
EXPERIMENTALNature therapy videos were produced with and without music for surgical patients.
Interventions
Audio relaxation technique created by an Icelandic Registered Nurse.
Audio recordings of non-lyrical relaxing music
Nature videos of the mountains, desert, Icelandic scenery, and ocean were provided via iPads for surgical patients
Nature videos of the mountains, forest, Icelandic landscape, and the ocean were provided via iPads for surgical patients
Eligibility Criteria
You may qualify if:
- Age range 18-75-years
- English or Icelandic speaking
- Cognitively alert and oriented to person, place, time, and situation
- Intact visual and auditory senses
You may not qualify if:
- History of substance abuse
- Chronic pain lasting more than six months
- Use of narcotic medication for more than six months
- Major psychiatric disorders
- Taking prescribed medications for thought disorders
- Having ophthalmology and/or auditory surgery or impairments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of San Franciscolead
- Fulbrightcollaborator
Study Sites (1)
LandspĂtala
Reykjavik, 101, Iceland
Related Publications (4)
Engwall M, Duppils GS. Music as a nursing intervention for postoperative pain: a systematic review. J Perianesth Nurs. 2009 Dec;24(6):370-83. doi: 10.1016/j.jopan.2009.10.013.
PMID: 19962104RESULTKline GA. Does a view of nature promote relief from acute pain? J Holist Nurs. 2009 Sep;27(3):159-66. doi: 10.1177/0898010109336138.
PMID: 19755566RESULTRoykulcharoen V: The effect of a systematic relaxation technique on postoperative pain in Thailand.
RESULTHansen MM. A feasibility pilot study on the use of complementary therapies delivered via mobile technologies on Icelandic surgical patients' reports of anxiety, pain, and self-efficacy in healing. BMC Complement Altern Med. 2015 Mar 28;15:92. doi: 10.1186/s12906-015-0613-8.
PMID: 25888344DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret M Hansen, Ed.D.
University of San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 4, 2014
First Posted
September 10, 2014
Study Start
March 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
September 10, 2014
Record last verified: 2014-09