Auricular Acupressure Relieves Constipation for Patients With Heart Failure in Hospital

NCT05988502 | Completed

• 1 other identifier: 110269-F
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate the effect of auricular acupressure (AA) to relieve constipation symptoms and improve quality of life in patients hospitalized for their heart failure. A total of 72 participants were randomly assigned and 68 (33 in the AA group and 35 in the control group) completed the study. Outcomes were measured by the Bristolv Stool Form Scale, Constipation Assessment Scale, Patient Assessment of Constipation Symptoms, Visual Scale Analog, Beck Anxiety Inventory and Beck Depression Inventory at baseline, Weeks 1 and 2, as well as Constitution in Chinese Medicine Questionnaire and Patient Assessment of Constipation Quality of Life at baseline and Week 2.

Conditions

Heart Failure; Auricular Acupressure; Constipation; Quality of Life; Depression, Anxiety

Keywords

Anxiety; auricular acupressure; constipation; heart failure; quality of life; Depression

Outcome Measures

Primary Outcomes (4)

• Change from Baseline constipation at 2 weeks by using the Bristolv Stool Form Scale

  Outcomes were assessed by using the Bristolv Stool Form Scale. This scale categorized tools between type 1 (hard lumps) and type 7 (watery diaphragm). Type 1 was separate hard lump like nuts(hard to pass), type 2 was sausage-shaped but lumpy, type 3 was like a sausage but with cracks on its surface, type 4 was like a sausage or snake, smooth and soft, type 5 was soft blobs with clear-cut edges (passed easily), type 6 is fluffy pieces with ragged edges (a mushy stool), and type 7 was watery, no solid pieces (entirely liquid). Stool types were then classified based on the Rome III criteria as stool types 1 and 2 as constipation, types 3, 4, and 5 as normal stool form, and types 6 and 7 as diarrhea,

  baseline, Weeks 1 and 2

• Change from Baseline constipation at 2 weeks by using the Constipation Assessment Scale

  Outcomes were assessed by using the Constipation Assessment Scale. The CAS comprised of 8 items, and each item used a 3-point Likert-type scale ranging 0\~2, with a total score of 0 to 16. A higher score indicated severer constipation symptom.

  baseline, Weeks 1 and 2

• Change from Baseline constipation at 2 weeks by using the Visual Scale Analog for constipation

  Outcomes were assessed by using the Visual Scale Analog for constipation. The VSAQ was used to measure the immediate severity of constipation, with a 10 cm straight line with 0 on the far left (0 score) and 10 cm (10 scores) on the far right. A score ≥ 3 indicated constipation, a higher score indicating severer constipation,

  baseline, Weeks 1 and 2

• Change from Baseline constipation at 2 weeks by using the Patient Assessment of Constipation Symptoms .

  Outcomes were assessed by using the Patient Assessment of Constipation Symptoms .This scale comprised of 12 items with 3 subscales, including stool symptoms, rectal symptoms, and abdominal symptoms. Each item used a 5-point Likert-type scale ranging 0\~4, with a total score of 0 to 48. A higher score indicated symptom severity.

  baseline, Weeks 1 and 2

Secondary Outcomes (4)

• Change from Baseline Body constitution in Chinese Medicine at 2 weeks

  at baseline, Weeks 2

• Change from Baseline Anxiety at 2 weeks

  at baseline, Weeks 1 and 2

• Change from Baseline Depression at 2 weeks

  at baseline, Weeks 1 and 2

• Patient Assessment of Constipation Quality of Life

  at baseline, Weeks 2

Study Arms (2)

auricular acupressure (AA) group

EXPERIMENTAL

the auricular acupressure (AA) group was given auricular acupressure for two weeks

Other: auricular acupressure

control group

NO INTERVENTION

all participants received the same routine care which was general heart failure care and medications for constipation therapy provided by the study hospital professionals. Prior to the study, every participant was assessed by the cardiologist and identified as being appropriate and safe.

Interventions

auricular acupressure OTHER

The well-trained researcher nurse in this study was performed the AA intervention. First of all, the participant was instructed to find a comfortable position. Disinfect the ears using cotton with 75 % alcohol was then provided and followed by placed vaccaria seeds (Beijing, China) with an adhesive patch onto the unilateral each selected auricular acupoint (left ear first) Participants were pressed each acupoint by thumb and index finger for one minute, four times a day, five days a week, remove the taped seeds on the 6th day, and then replaced the opposite ear two days after. They were noted that they experienced various sensations while pressing, including numbness, swelling, mild pain, or warmth. Seeds were taped on the other side of the ear weekly for two weeks. Two TCM physicians verified the conduct of the AA protocol, which consisted of a selection of acupoints, length of stimulation time, finding location of acupoint, and procedure of practice.

auricular acupressure (AA) group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New York Heart Association (NYHA) functional classes I-III
• Constipation(had fewer than three bowel movements a week)
• Conscious clear and communicable

You may not qualify if:

• Other serious diseases
• Wounds or infections in both ears

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Heart Failure; Constipation; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Yi-Ting Chen

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The random sequence of numbers was separately and sequentially stored in sealed, opaque envelopes that were opened in front of the participants in the predetermined order, which determined their group.The participants do not know their own group, the researcher knows the participant's group and intervenes according to the participant's group, and the outcomes Assessor conducts the outcomes assessment without knowing the participant's group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants were randomized into two groups by a research team not involved in the study intervention or data collection. The randomization process was accomplished through a computer-generated sequence of random numbers, and permuted block randomization was employed with four in each block. The random sequence of numbers was separately and sequentially stored in sealed, opaque envelopes that were opened in front of the participants in the predetermined order, which determined their group allocation.the auricular acupressure (AA) group was given auricular acupressure for two weeks and the control group received usual care for heart failure during the same study period. Data were collected consisted of three repeated measurement time points at baseline, Week 1, and Week 2.

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 14, 2023
• Study Start: March 6, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)