Clinical trial NCT05988502: Auricular Acupressure Relieves Constipation for Patients With Heart Failure in Hospital
Official title: Auricular Acupressure Relieves Constipation for Patients With Heart Failure in Hospital: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Auricular Acupressure
Constipation
Quality of Life
Depression, Anxiety
Keywords: Anxiety
auricular acupressure
constipation
heart failure
quality of life
Depression
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 1. Study Design This was a parallel randomized controlled trial with two groups; 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.
2. Participants This study consecutively recruited patients who were hospitalized for treating heart failure from the cardiology ward of the a medical center in northern Taiwan. Patients who aged over 20 years and had the New York Heart Association (NYHA) functional classes I-III, constipation(had fewer than three bowel movements a week), and conscious clear and communicable were included, while those who had serious diseases or wounds or infections in both ears were excluded. The sample size required for the study was estimated using G-power software vers.3.1. (Heinrich Heine Universitat, Dusseldorf, Germany), with an effect size of 0.3 referring to the previous study on constipation, the significance level (α) at .05, and 80% statistical power. With considering a 10% dropout rate, a total of 72
3. Randomization and allocation concealment 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.
4. The auricular acupressure (AA) intervention The AA intervention selected seven acupoints on auricle, including Shenmen (TF4), Intestine (CO7), Rectum (HX2), San Jiao (CO17), Spleen (CO13), Lung (CO14) and Subcortex (AT4), as seen Figure 2 (intestine, rectum, San Jiao, spleen, lung, and subcortex).

   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. In addition, 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. Data collection was conducted by the same researcher nurse at baseline, Week 1, and Week 2.
5. Measurements Outcomes were assessed by using the Bristolv Stool Form Scale, Constipation Assessment Scale, Patient Assessment of Constipation Symptoms, Visual Scale Analog, Constitution in Chinese Medicine Questionnaire, Beck Anxiety Inventory, Beck Depression Inventory II and Patient Assessment of Constipation Quality Of Life；The 1th week follow-up assessment instruments included the Bristolv Stool Form Scale, Constipation Assessment Scale, Patient Assessment of Constipation Symptoms, Visual Scale Analog, Beck Anxiety Inventory and Beck Depression Inventory II.
6. Statistical analysis Data were analyzed using SPSS 26.0 for Windows (IBM, Chicago, IL, USA). continuous variables are reported as means and standard deviations (SD), and categorical variables are reported as the number of samples and percentages. Homogeneity was tested by the Chi-square test and independent t test. Intervention effects on outcomes between the groups across repeated measurement times were analyzed by the linear mixed model using an exchangeable working correlation structure and time treated as a categorical variable that was represented by two dummy-coded variables. This study a value of p \< 0.05 was considered statistically significant.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Other serious diseases
* Wounds or infections in both ears

Primary outcomes:
measure: Change from Baseline constipation at 2 weeks by using the Bristolv Stool Form Scale
timeFrame: baseline, Weeks 1 and 2
measure: Change from Baseline constipation at 2 weeks by using the Constipation Assessment Scale
timeFrame: baseline, Weeks 1 and 2
measure: Change from Baseline constipation at 2 weeks by using the Visual Scale Analog for constipation
timeFrame: baseline, Weeks 1 and 2
measure: Change from Baseline constipation at 2 weeks by using the Patient Assessment of Constipation Symptoms .
timeFrame: baseline, Weeks 1 and 2
Secondary outcomes:
measure: Change from Baseline Body constitution in Chinese Medicine at 2 weeks
timeFrame: at baseline, Weeks 2
measure: Change from Baseline Anxiety at 2 weeks
timeFrame: at baseline, Weeks 1 and 2
measure: Change from Baseline Depression at 2 weeks
timeFrame: at baseline, Weeks 1 and 2
measure: Patient Assessment of Constipation Quality of Life
timeFrame: at baseline, Weeks 2
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Yi-Ting Chen
role: PRINCIPAL_INVESTIGATOR
References: