Anxiety DisorderNCT01553578
Healing Touch or Guided Imagery In Treating Pain, Fatigue, Nausea, and Anxiety in Patients Undergoing Chemotherapy
A study testing questionnaire administration, therapeutic touch and management of therapy complications in people with Anxiety Disorder and Fatigue, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This randomized clinical trial studies healing touch or guided imagery in treating pain, fatigue, nausea, and anxiety in patients undergoing chemotherapy. Healing touch and guided imagery may help treat complications caused by chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorder, Fatigue, Malignant Neoplasm
- What is being tested?
- questionnaire administration, therapeutic touch and management of therapy complications
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients at the outpatient chemotherapy area will be enrolled without consideration for type of cancer or chemotherapeutic agents to be used
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: The Efficacy of Healing Touch Versus Guided Imagery on Pain, Fatigue, Nausea, and Anxiety in Patients' Receiving Outpatient Chemotherapy
This randomized clinical trial studies healing touch or guided imagery in treating pain, fatigue, nausea, and anxiety in patients undergoing chemotherapy. Healing touch and guided imagery may help treat complications caused by chemotherapy. It is not yet known whether healing touch or guided imagery is more effective in treating pain, fatigue, nausea, and anxiety in patients undergoing chemotherapy
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if the provision of healing touch or guided imagery during outpatient chemotherapy is associated with decreased pain, fatigue, nausea and anxiety when compared to standard outpatient treatment protocols.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM A: Patients receive 30 minutes of healing touch therapy comprising magnetic clearing, pain drains, hands in motion/hands still and mind clearing.
ARM B: Patients listen to guided imagery audiotapes for 30 minutes
ARM C: Patients receive standard of care.
- Conditions
- Anxiety Disorder, Fatigue, Malignant Neoplasm, Nausea and Vomiting, Pain
- Being tested
- questionnaire administration, therapeutic touch, management of therapy complications, standard follow-up care
- Medical subject headings
- Anxiety Disorders, Fatigue, Neoplasms, Nausea, Vomiting, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Ancillary studies
therapeutic touchProcedure or surgery
Also called healing touch
Receive healing touch therapy
management of therapy complicationsBehavioural
Also called complications of therapy, management of
Receive healing touch therapy
management of therapy complicationsBehavioural
Also called complications of therapy, management of
Receive guided imagery audiotapes
standard follow-up careProcedure or surgery
Receive standard care
| Study group | Role | What they receive |
|---|---|---|
| Arm A (healing touch therapy) | Experimental | Patients receive 30 minutes of healing touch therapy consisting of magnetic clearing, pain drains, hands in motion/hands still and mind clearing. Receives: Other: questionnaire administration; Procedure: therapeutic touch; Behavioral: management of therapy complications |
| Arm B (guided imagery) | Experimental | Patients listen to guided imagery audiotapes for 30 minutes. Receives: Other: questionnaire administration; Behavioral: management of therapy complications |
| Arm C (standard care) | Active comparator | Patients receive standard of care. Receives: Other: questionnaire administration; Procedure: standard follow-up care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores for each patient on pain scale
Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.
Measured: Approximately 6 months
Change scores for each patient on fatigue scale
Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.
Measured: Approximately 6 months
Change scores for each patient on nausea scale
Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.
Measured: Approximately 6 months
Change scores for each patient on anxiety scale
Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.
Measured: Approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lisa Hodges, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553578
- Sponsor's protocol ID
- IRB00018805
- Other IDs
- NCI-2012-00164, CCCWFU 97511
- Status last verified
- Jul 2018
- First submitted
- 9 Mar 2012
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Healing Touch Versus Guided Imagery on Pain, Fatigue, Nausea, and Anxiety in Patients' Receiving Outpatient Chemotherapy
- ClinicalTrials.gov ID
- NCT01553578
- Acronym / sponsor ID
- IRB00018805
- Conditions
- Anxiety Disorder, Fatigue, Malignant Neoplasm, Nausea and Vomiting, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial studies healing touch or guided imagery in treating pain, fatigue, nausea, and anxiety in patients undergoing chemotherapy. Healing touch and guided imagery may help treat complications caused by chemotherapy. It is not yet known whether healing touch or guided imagery is more effective in treating pain, fatigue, nausea, and anxiety in patients undergoing chemotherapy
Detailed description
PRIMARY OBJECTIVES:
- To determine if the provision of healing touch or guided imagery during outpatient chemotherapy is associated with decreased pain, fatigue, nausea and anxiety when compared to standard outpatient treatment protocols.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM A: Patients receive 30 minutes of healing touch therapy comprising magnetic clearing, pain drains, hands in motion/hands still and mind clearing.
ARM B: Patients listen to guided imagery audiotapes for 30 minutes
ARM C: Patients receive standard of care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (healing touch therapy) | Experimental | Other: questionnaire administration, Procedure: therapeutic touch, Behavioral: management of therapy complicationsPatients receive 30 minutes of healing touch therapy consisting of magnetic clearing, pain drains, hands in motion/hands still and mind clearing. |
| Arm B (guided imagery) | Experimental | Other: questionnaire administration, Behavioral: management of therapy complicationsPatients listen to guided imagery audiotapes for 30 minutes. |
| Arm C (standard care) | Active comparator | Other: questionnaire administration, Procedure: standard follow-up carePatients receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients at the outpatient chemotherapy area will be enrolled without consideration for type of cancer or chemotherapeutic agents to be used
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administrationAncillary studies | Other | Arm A (healing touch therapy), Arm B (guided imagery), Arm C (standard care) |
| therapeutic touchAlso: healing touchReceive healing touch therapy | Procedure or surgery | Arm A (healing touch therapy) |
| management of therapy complicationsAlso: complications of therapy, management ofReceive healing touch therapy | Behavioural | Arm A (healing touch therapy) |
| management of therapy complicationsAlso: complications of therapy, management ofReceive guided imagery audiotapes | Behavioural | Arm B (guided imagery) |
| standard follow-up careReceive standard care | Procedure or surgery | Arm C (standard care) |
Primary outcome
Change scores for each patient on pain scale
Time frame: Approximately 6 months
Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.
Change scores for each patient on fatigue scale
Time frame: Approximately 6 months
Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.
Change scores for each patient on nausea scale
Time frame: Approximately 6 months
Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.
Change scores for each patient on anxiety scale
Time frame: Approximately 6 months
Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Hodges principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration, therapeutic touch and management of therapy complications in people with Anxiety Disorder and Fatigue, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores for each patient on pain scale (time frame: Approximately 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.