Effects of Complementary Therapies Delivered Via Mobile Technologies

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236455
• Other study ID #: S5862
• Status: Completed
• Phase: N/A
• First received: September 4, 2014
• Last updated: September 8, 2014
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: September 2014
• Source: University of San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Pain
• Anxiety
• Self Efficacy

Intervention

Behavioral:
• Audio Relaxation Technique
Audio relaxation technique created by an Icelandic Registered Nurse.
• Medical Music Intervention
Audio recordings of non-lyrical relaxing music
• Nature Therapy without Music
Nature videos of the mountains, desert, Icelandic scenery, and ocean were provided via iPads for surgical patients
• Nature Therapy with Music
Nature videos of the mountains, forest, Icelandic landscape, and the ocean were provided via iPads for surgical patients

Locations

Country	Name	City	State
Iceland	Landspítala	Reykjavik

Sponsors (2)

Lead Sponsor	Collaborator
University of San Francisco	Fulbright

Country where clinical trial is conducted

Iceland, 

References & Publications (3)

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. Review. — View 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. Review. — View Citation

Roykulcharoen V: The effect of a systematic relaxation technique on postoperative pain in Thailand.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in self-efficacy in healing using the General Self-Efficacy Scale (GSE)	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	No
Primary	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	No
Secondary	Change in baseline pain level using the Numeric Rating Scale (NRS)	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	No

External Links

•   National Center for Complementary Medicine (NIH)