Acupressure for the Reduction of Anxiety in Patients Receiving Cancer-Directed Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
This clinicaI trial is being done to determine if acupressure is helpful to reduce anxiety related to chemotherapy, compared with "sham" (or placebo) acupressure in patients with cancer. Anxiety, experienced by many patients with cancer, can be related to chemotherapy and may contribute to other symptoms, such as nausea and poor quality of life. Some patients diagnosed with cancer express interest in non-medicine ways to manage symptoms. Acupressure is the application of non-invasive finger pressure along energy points throughout the body in order to relieve pain and induce a feeling of well-being. Previous research has shown that acupressure can help both adults and children with their anxiety in certain situations, such as after surgery. Patients can be taught how to do the acupressure on themselves, making this an intervention that can be done anywhere. Acupressure is well tolerated with minimal reports of adverse reactions. Undergoing acupressure may be effective in reducing anxiety in cancer patients receiving chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
NURSE-LED INTERVENTION: Age >= 18 years and be diagnosed with cancer
NURSE-LED INTERVENTION: Undergoing systemic, antineoplastic therapy
NURSE-LED INTERVENTION: Ability to provide oral consent
NURSE-LED INTERVENTION: Willingness to undergo a nurse-led acupressure intervention
Disqualifiers
Prior experiences with acupressure, or training in acupressure points
Trial design
Design model
Parallel
Treatments tested in this trial
Acupressure Therapy
Procedure/SurgeryUndergo true acupressure
Acupressure Therapy - placebo
Procedure/SurgeryUndergo sham acupressure
Acupressure Therapy - self-administered
Procedure/SurgeryUndergo self-administered acupressure
Health Promotion and Education
Other interventionReceive educational handouts
Survey Administration
Other interventionAncillary studies
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Arm I (true acupressure)Experimental treatment 4 interventions
Group B: Arm II (sham acupressure)Sham comparator 4 interventions
Trial outcomes
Primary outcomes
1
Change in acute anxiety
Will be compared between treatment groups. This will be measured by changes in responses to a single item, "Please rate the following symptoms, based on how you feel at the current time (please indicate the one most correct response)," with responses provided on a Likert scale from 0 (no anxiety) to 10 (worst possible anxiety).
Time frame
Up to 2 weeksSecondary outcomes
1
Associations between changes in anxiety and demographic variables
Demographic variables, including age, gender identity, race/ethnicity, cancer type, cancer stage, and cancer therapy type, will be compared with answers to anxiety question specified in Outcome 1.
Time frame
Up to 2 weeks2
Efficacy of self-administered acupressure
Assessed by the number of participants in each arm (true vs sham) who are willing to complete self-administered acupressure.
Time frame
Up to 2 weeks3
Changes in anxiety-related symptoms
Assessed using an anxiety questionnaire administered at baseline and post-intervention. Seven items (anxiety, nausea, pain, wellbeing, relaxation, worry, and distress) are rated on a scale of 0 (strongly disagree) to 10 (strongly agree).
Time frame
Up to 2 weeksSponsors and contacts
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Source ClinicalTrials.gov