<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02236455</url>
  </required_header>
  <id_info>
    <org_study_id>S5862</org_study_id>
    <nct_id>NCT02236455</nct_id>
  </id_info>
  <brief_title>Effects of Complementary Therapies Delivered Via Mobile Technologies</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fulbright</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effects of complementary therapies delivered&#xD;
      via mobile technologies have a therapeutic effect on surgical patients' anxiety, pain, and&#xD;
      self-efficacy in healing reports before, following, and at 10-day follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients scheduled for same-day surgery (SDS) often experience state anxiety, which may&#xD;
      result in increased perceptions of pain and lower self-efficacy in healing. Complementary&#xD;
      therapies (CT), such as relaxation technique, massage, guided imagery, and acupuncture have&#xD;
      been shown to benefit patients undergoing surgery. The aim of this study was to examine the&#xD;
      effects of audio relaxation technique (ART), music intervention (MI), nature video&#xD;
      application with music (NVAM), and nature video application without music (NVA) delivered via&#xD;
      mobile technologies on patients' state anxiety, pain perception, and perceived self-efficacy&#xD;
      in healing.&#xD;
&#xD;
      Methods A randomized controlled trial (RCT) involving 105 SDS patients, who were assigned to&#xD;
      an ART (n = 25), MI (n = 25), NVAM (n = 15), NVA (n = 16), or a control group (n = 24) were&#xD;
      assessed for state anxiety via the State Trait Anxiety Inventory (STAI), self-reported pain&#xD;
      using the numeric rating scale (NRS), and self-efficacy with the general self-efficacy scale&#xD;
      (GSE) four days prior to surgery, immediately prior and following the surgical intervention,&#xD;
      and at day five post-operative.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline state anxiety via the State Trait Anxiety Scale (STAI)</measure>
    <time_frame>Ten days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in baseline pain level using the Numeric Rating Scale (NRS)</measure>
    <time_frame>Ten Days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in self-efficacy in healing using the General Self-Efficacy Scale (GSE)</measure>
    <time_frame>Ten Days</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Acute Pain</condition>
  <condition>Anxiety</condition>
  <condition>Self Efficacy</condition>
  <arm_group>
    <arm_group_label>Audio Relaxation technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical Music Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Music intervention is use to assist with relaxation and reduce stress levels in patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nature Therapy without Music</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ecotherapy is the use of nature to reduce stress and to increase levels of well-being in patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nature Therapy with Music</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nature therapy videos were produced with and without music for surgical patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Audio Relaxation Technique</intervention_name>
    <description>Audio relaxation technique created by an Icelandic Registered Nurse.</description>
    <arm_group_label>Audio Relaxation technique</arm_group_label>
    <other_name>Guided Imagery</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Medical Music Intervention</intervention_name>
    <description>Audio recordings of non-lyrical relaxing music</description>
    <arm_group_label>Medical Music Intervention</arm_group_label>
    <other_name>Music Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nature Therapy without Music</intervention_name>
    <description>Nature videos of the mountains, desert, Icelandic scenery, and ocean were provided via iPads for surgical patients</description>
    <arm_group_label>Nature Therapy without Music</arm_group_label>
    <other_name>Ecotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nature Therapy with Music</intervention_name>
    <description>Nature videos of the mountains, forest, Icelandic landscape, and the ocean were provided via iPads for surgical patients</description>
    <arm_group_label>Nature Therapy with Music</arm_group_label>
    <other_name>Ecotherapy with Music</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age range 18-75-years&#xD;
&#xD;
          -  English or Icelandic speaking&#xD;
&#xD;
          -  Cognitively alert and oriented to person, place, time, and situation&#xD;
&#xD;
          -  Intact visual and auditory senses&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of substance abuse&#xD;
&#xD;
          -  Chronic pain lasting more than six months&#xD;
&#xD;
          -  Use of narcotic medication for more than six months&#xD;
&#xD;
          -  Major psychiatric disorders&#xD;
&#xD;
          -  Taking prescribed medications for thought disorders&#xD;
&#xD;
          -  Having ophthalmology and/or auditory surgery or impairments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margaret M Hansen, Ed.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Landspítala</name>
      <address>
        <city>Reykjavik</city>
        <zip>101</zip>
        <country>Iceland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iceland</country>
  </location_countries>
  <link>
    <url>http://nccam.nih.gov/</url>
    <description>National Center for Complementary Medicine (NIH)</description>
  </link>
  <results_reference>
    <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>
    <PMID>19962104</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>19755566</PMID>
  </results_reference>
  <results_reference>
    <citation>Roykulcharoen V: The effect of a systematic relaxation technique on postoperative pain in Thailand.</citation>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 8, 2014</last_update_submitted>
  <last_update_submitted_qc>September 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of San Francisco</investigator_affiliation>
    <investigator_full_name>Margaret M. Hansen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>complementary medicine</keyword>
  <keyword>state anxiety</keyword>
  <keyword>acute pain</keyword>
  <keyword>self-efficacy</keyword>
  <keyword>surgery</keyword>
  <keyword>medical music intervention</keyword>
  <keyword>nature therapy</keyword>
  <keyword>relaxation technique</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02236455
org study id: S5862
nct id: NCT02236455
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change from baseline state anxiety via the State Trait Anxiety Scale (STAI)
time frame: Ten days
description: 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.
measure: Change in baseline pain level using the Numeric Rating Scale (NRS)
time frame: Ten Days
description: 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.
measure: Change in self-efficacy in healing using the General Self-Efficacy Scale (GSE)
time frame: Ten Days
description: 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.
arm group label: Audio Relaxation technique
arm group type: Experimental
description: 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.
arm group label: Medical Music Intervention
arm group type: Experimental
description: Music intervention is use to assist with relaxation and reduce stress levels in patients.
arm group label: Nature Therapy without Music
arm group type: Experimental
description: Ecotherapy is the use of nature to reduce stress and to increase levels of well-being in patients.
arm group label: Nature Therapy with Music
arm group type: Experimental
description: Nature therapy videos were produced with and without music for surgical patients.
intervention type: Behavioral
intervention name: Audio Relaxation Technique
description: Audio relaxation technique created by an Icelandic Registered Nurse.
arm group label: Audio Relaxation technique
other name: Guided Imagery
intervention type: Behavioral
intervention name: Medical Music Intervention
description: Audio recordings of non-lyrical relaxing music
arm group label: Medical Music Intervention
other name: Music Therapy
intervention type: Behavioral
intervention name: Nature Therapy without Music
description: Nature videos of the mountains, desert, Icelandic scenery, and ocean were provided via iPads for surgical patients
arm group label: Nature Therapy without Music
other name: Ecotherapy
intervention type: Behavioral
intervention name: Nature Therapy with Music
description: Nature videos of the mountains, forest, Icelandic landscape, and the ocean were provided via iPads for surgical patients
arm group label: Nature Therapy with Music
other name: Ecotherapy with Music
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Margaret M Hansen, Ed.D.
role: Principal Investigator
affiliation: University of San Francisco
facility: 
country: Iceland
url: http://nccam.nih.gov/
description: National Center for Complementary Medicine (NIH)
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.
PMID: 19962104
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.
PMID: 19755566
citation: Roykulcharoen V: The effect of a systematic relaxation technique on postoperative pain in Thailand.
responsible party type: Principal Investigator
investigator affiliation: University of San Francisco
investigator full name: Margaret M. Hansen
investigator title: Associate Professor
mesh term: Acute Pain
mesh term: Anxiety Disorders