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NCT06322615 Clinical Trial

Acupressure for Reducing Anxiety in Patients Undergoing Chemotherapy

Malignant Solid Neoplasm Clinical Trial

Official title:
Acupressure for Anxiety: A Pilot Study of a Nurse-Led Acupressure Intervention for Patients Receiving Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06322615
Other study ID # MC221001
Secondary ID NCI-2024-0053823
Status Recruiting
Phase N/A
First received
Last updated
Start date August 8, 2023
Est. completion date December 31, 2025

Study information
Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial evaluates whether acupressure is helpful to reduce anxiety related to chemotherapy. Anxiety is experienced by many patients with cancer. Anxiety 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-medicinal ways to manage symptoms. Acupressure is a noninvasive intervention that can be used for many different symptoms. Acupressure is well tolerated with minimal reports of adverse reactions, making it a good choice for patients with cancer. This study may help researchers learn whether acupressure is useful for managing anxiety in patients undergoing chemotherapy.

Description:

PRIMARY OBJECTIVES: I. Evaluate the feasibility of a nurse- and patient-applied acupressure intervention for patients with anxiety associated with active cancer-directed therapy. II. Patient-reported changes in acute anxiety associated with both the nurse and self-led acupressure interventions will be ascertained. OUTLINE: Patients undergo acupressure over 15-120 seconds at a time for up to 15 minutes. After completion of the session, patients may optionally receive an education session on using acupressure at home. After completion of study intervention, patients who opted to receive education about using acupressure at home are followed up at 1 week.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Be over 18 years of age - Be actively undergoing chemotherapy in the Mayo Clinic chemotherapy unit - Report anxiety as a 1 or higher, on a scale from 0 (no anxiety) to 4 (severe anxiety) - Be willing to undergo a short acupressure session Exclusion Criteria: - Does not meet the inclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Acupressure Therapy
Undergo acupressure
Other:
• Educational Intervention
Receive education session about using acupressure at home
• Electronic Health Record Review
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients approached about undergoing acupressure intervention (Feasibility) Assessed by the number of patients approached about undergoing acupressure intervention. Up to 1 year
Primary Number of patients interested in the initial acupressure intervention in the chemotherapy unit (Feasibility) Assessed by the number of patients who express interest in the initial acupressure intervention in the chemotherapy unit. Up to 1 year
Primary Number of patients interested in the home acupressure intervention (Feasibility) Assessed by the number of patients who express interest in the home acupressure intervention. Up to 1 year
Primary Time taken for each nurse-led acupressure intervention in the chemotherapy unit (Feasibility) Assess by the time recorded for ach nurse-led acupressure intervention in the chemotherapy unit. Up to 1 year
Primary Patient-reported changes in acute anxiety Assessed with a brief anxiety questionnaire that inquires about the three different domains of anxiety: cognitive symptoms, emotional symptoms, and physical symptoms. Seven questions are answered using 11-point (0-10) scales with different values assigned to the scale per question (e.g. 0=no anxiety/10=worst possible anxiety or 0=strongly disagree/10=strongly agree). At baseline, after a one-time nurse-administered acupressure session, and after one week of self-administered acupressure sessions
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