Effects of Complementary Therapies Delivered Via Mobile Technologies

Not Applicable

Completed

• Conditions: Anxiety; Acute Pain; Self Efficacy
• Interventions: Behavioral: Audio Relaxation Technique; Behavioral: Nature Therapy without Music; Behavioral: Medical Music Intervention; Behavioral: Nature Therapy with Music

• Registration Number: NCT02236455
• Lead Sponsor: University of San Francisco

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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-08
• Last Update Submitted: 2014-09-08
• Study First Posted: 2014-09-10
• Last Update Posted: 2014-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Audio Relaxation technique	Audio Relaxation Technique	Relaxation 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.
Nature Therapy without Music	Nature Therapy without Music	Ecotherapy is the use of nature to reduce stress and to increase levels of well-being in patients.
Medical Music Intervention	Medical Music Intervention	Music intervention is use to assist with relaxation and reduce stress levels in patients.
Nature Therapy with Music	Nature Therapy with Music	Nature therapy videos were produced with and without music for surgical patients.

Primary Outcome Measures

Name	Time	Method
Change from baseline state anxiety via the State Trait Anxiety Scale (STAI)	Ten days	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.

Secondary Outcome Measures

Name	Time	Method
Change in baseline pain level using the Numeric Rating Scale (NRS)	Ten Days	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.

Trial Locations

Locations (1)

Landspítala; 🇮🇸 Reykjavik, Iceland