Clinical trial NCT02236455: Effects of Complementary Therapies Delivered Via Mobile Technologies
Official title: Effects of Complementary Therapies Delivered Via Mobile Technologies on Surgical Patients' Reports of Anxiety, Pain, and Self-Efficacy in Healing: A Pilot Randomized Controlled Trial in Iceland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Anxiety
Self Efficacy
Keywords: complementary medicine
state anxiety
acute pain
self-efficacy
surgery
medical music intervention
nature therapy
relaxation technique
Lead sponsor: University of San Francisco
Sponsor class: OTHER
Collaborators: name: Fulbright
First posted: 2014-09-10
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Patients scheduled for same-day surgery (SDS) often experience state anxiety, which may result in increased perceptions of pain and lower self-efficacy in healing. Complementary therapies (CT), such as relaxation technique, massage, guided imagery, and acupuncture have been shown to benefit patients undergoing surgery. The aim of this study was to examine the effects of audio relaxation technique (ART), music intervention (MI), nature video application with music (NVAM), and nature video application without music (NVA) delivered via mobile technologies on patients' state anxiety, pain perception, and perceived self-efficacy in healing.

Methods 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.

Eligibility criteria: Inclusion Criteria:

* Age range 18-75-years
* English or Icelandic speaking
* Cognitively alert and oriented to person, place, time, and situation
* Intact visual and auditory senses

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline state anxiety via the State Trait Anxiety Scale (STAI)
timeFrame: Ten days
Secondary outcomes:
measure: Change in baseline pain level using the Numeric Rating Scale (NRS)
timeFrame: Ten Days
Other outcomes:
measure: Change in self-efficacy in healing using the General Self-Efficacy Scale (GSE)
timeFrame: Ten Days
Locations:
city: Reykjavik
country: Iceland
facility: Landspítala
Study officials:
affiliation: University of San Francisco
name: Margaret M Hansen, Ed.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kline GA. Does a view of nature promote relief from acute pain? J Holist Nurs. 2009 Sep;27(3):159-66. doi: 10.1177/0898010109336138.
citation: Roykulcharoen V: The effect of a systematic relaxation technique on postoperative pain in Thailand.
citation: Hansen 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.