ConstıpatıonNCT05506397
Acupressure for Constipation in the Elderly
A study testing Acupressure in people with Constıpatıon, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study was carried out to determine the effect of acupressure applied to LI4, CV12, ST25 and ST36 acupuncture points for a total of 21 minutes, three to each point, on the symptoms of constipation and quality of life of elderly individuals. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Constıpatıon
- What is being tested?
- Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2021to 30 Nov 2021
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 and over,
- Able to answer cognitive questions
- Able to do daily tasks unaided
- Experiencing two or more of the Rome IV criteria
Who cannot join
- Communication and adaptation difficulties,
- Malignant, intestinal obstruction, fecal incontinence, diarrhea, irritable bowel syndrome, abdominal infection, etc. have a contraindication to continue the intervention, addicted to bed
- Chronic pain requiring long-term analgesic intake and using psychiatric medication,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupressure on Constıpatıon Symptoms and Quality of Lıfe in Elderly People
This study was carried out to determine the effect of acupressure applied to LI4, CV12, ST25 and ST36 acupuncture points for a total of 21 minutes, three to each point, on the symptoms of constipation and quality of life of elderly individuals.
Read the detailed description
The study is a qualitative and quantitative mixed method, double-blind, randomized, placebo-controlled, pretest-posttest control group study. In this study; a total of 81 elderly individuals over the age of 65 and diagnosed with constipation in a family health center were included, 41 individuals in the acupressure group and 40 individuals in the placebo control group. Ethics committee approval, informed voluntary consent of the elderly and all other necessary permissions to conduct the study were obtained before the study.
The data of the study were collected using the Individual Identification Form, the Constipation Assessment Scale (CAS), the Constipation Quality of Life Scale (PAC-QOL), the Visual Analog Scale (VAS), the Individual Follow-up Form and the Semi-Structured Interview Form. Acupressure was applied to individuals in the acupressure group every day for 12 days, and placebo acupressure was applied to individuals in the placebo acupressure group at the same time and in line with the same protocol. In addition, individual in-depth interviews were conducted with the individuals in the acupressure group after the applications were completed.
Quantitative data were evaluated using the IBM SPSS Statistics for Windows 24.0 package program. In the evaluation of quantitative data; Independent groups t test / Mann Whitney U test, dependent groups t-test, two-way mixed pattern ANOVA, multiple regression analysis (enter method) were used and p<0.05 value was considered statistically significant. In the evaluation of qualitative data, descriptive and content analysis methods were used.
- Conditions
- Constıpatıon
- Being tested
- Acupressure
- Keywords
- Acupressure, Constipation, Quality of life, Elderly people, Nursing
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Acupressure is a technique based on stimulating certain points on the body with stimulation methods such as hands and fingers.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure (intervention group) | Experimental | Acupressure was applied to individuals in the acupressure group every day for 12 days. Receives: Other: Acupressure |
| control group | Placebo comparator | Placebo acupressure was applied to the individuals in the placebo acupressure group in accordance with the same protocol. Receives: Other: Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation Assessment Scale (CAS)
It was used to evaluate the symptoms of constipation.
Measured: Change from Baseline symptoms of constipation at 12 days
Secondary outcomes (3)
Constipation Quality of Life Scale (PAC-QOL)
It was used to evaluate the quality of life.
Measured: Change from baseline constipation-related quality of life at 12 days
Visual Analog Scale (VAS)
It was used to assess the level of defecation comfort.
Measured: Change from baseline defecation comfort at 12 days
Number of Defecation
12-day total number of defecations
Measured: Change from baseline number of defecations at 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start24 Feb 2021
- Primary completion30 Jun 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ConstıpatıonStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- Model description
- randomized, placebo-controlled, pretest-posttest control group study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- Nigde Omer Halisdemir University, Kayseri City Hospital
- Responsible party
- Principal investigator, Tuğba AYDEMİR, TC Erciyes University
- Investigators
- Sultan TAŞCI, Prof. Dr., Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506397
- Sponsor's protocol ID
- ErciyesU2
- Status last verified
- Aug 2022
- First submitted
- 23 Jul 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol
Publications
Shin J, Park H. Effects of Auricular Acupressure on Constipation in Patients With Breast Cancer Receiving Chemotherapy: A Randomized Control Trial. West J Nurs Res. 2018 Jan;40(1):67-83. doi: 10.1177/0193945916680362. Epub 2016 Nov 30.
PubMed 27903827Wang PM, Hsu CW, Liu CT, Lai TY, Tzeng FL, Huang CF. Effect of acupressure on constipation in patients with advanced cancer. Support Care Cancer. 2019 Sep;27(9):3473-3478. doi: 10.1007/s00520-019-4655-1. Epub 2019 Jan 24.
PubMed 30675666Jung ES, Chang AK. Effects of Auricular Acupressure in Patients on Hemodialysis. J Nurs Res. 2020 Aug;28(4):e106. doi: 10.1097/jnr.0000000000000378.
PubMed 32379107Lee EJ, Frazier SK. The efficacy of acupressure for symptom management: a systematic review. J Pain Symptom Manage. 2011 Oct;42(4):589-603. doi: 10.1016/j.jpainsymman.2011.01.007. Epub 2011 Apr 30.
PubMed 21531533Aydemir T, Tasci S, Bayraktar M, Saz A. The effect of acupressure on constipation symptoms and quality of life among older people: a mixed-methods study. Eur Geriatr Med. 2023 Oct;14(5):1135-1144. doi: 10.1007/s41999-023-00842-6. Epub 2023 Jul 21.
PubMed 37477804
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure on Constıpatıon Symptoms and Quality of Lıfe in Elderly People
- ClinicalTrials.gov ID
- NCT05506397
- Acronym / sponsor ID
- ErciyesU2
- Conditions
- Constıpatıon
- Keywords
- Acupressure, Constipation, Quality of life, Elderly people, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- Nigde Omer Halisdemir University, Kayseri City Hospital
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 18 Aug 2022 (actual)
- 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 study was carried out to determine the effect of acupressure applied to LI4, CV12, ST25 and ST36 acupuncture points for a total of 21 minutes, three to each point, on the symptoms of constipation and quality of life of elderly individuals.
Detailed description
The study is a qualitative and quantitative mixed method, double-blind, randomized, placebo-controlled, pretest-posttest control group study. In this study; a total of 81 elderly individuals over the age of 65 and diagnosed with constipation in a family health center were included, 41 individuals in the acupressure group and 40 individuals in the placebo control group. Ethics committee approval, informed voluntary consent of the elderly and all other necessary permissions to conduct the study were obtained before the study.
The data of the study were collected using the Individual Identification Form, the Constipation Assessment Scale (CAS), the Constipation Quality of Life Scale (PAC-QOL), the Visual Analog Scale (VAS), the Individual Follow-up Form and the Semi-Structured Interview Form. Acupressure was applied to individuals in the acupressure group every day for 12 days, and placebo acupressure was applied to individuals in the placebo acupressure group at the same time and in line with the same protocol. In addition, individual in-depth interviews were conducted with the individuals in the acupressure group after the applications were completed.
Quantitative data were evaluated using the IBM SPSS Statistics for Windows 24.0 package program. In the evaluation of quantitative data; Independent groups t test / Mann Whitney U test, dependent groups t-test, two-way mixed pattern ANOVA, multiple regression analysis (enter method) were used and p<0.05 value was considered statistically significant. In the evaluation of qualitative data, descriptive and content analysis methods were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, placebo-controlled, pretest-posttest control group study.
| Arm | Type | Receives |
|---|---|---|
| Acupressure (intervention group) | Experimental | Other: AcupressureAcupressure was applied to individuals in the acupressure group every day for 12 days. |
| control group | Placebo comparator | Other: AcupressurePlacebo acupressure was applied to the individuals in the placebo acupressure group in accordance with the same protocol. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged 65 and over,
- Able to answer cognitive questions
- Able to do daily tasks unaided
- Experiencing two or more of the Rome IV criteria
Key exclusion criteria (3 listed)
- Communication and adaptation difficulties,
- Malignant, intestinal obstruction, fecal incontinence, diarrhea, irritable bowel syndrome, abdominal infection, etc. have a contraindication to continue the intervention, addicted to bed
- Chronic pain requiring long-term analgesic intake and using psychiatric medication,
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 |
|---|---|---|
| AcupressureAcupressure is a technique based on stimulating certain points on the body with stimulation methods such as hands and fingers. | Other | Acupressure (intervention group), control group |
Primary outcome
Constipation Assessment Scale (CAS)
Time frame: Change from Baseline symptoms of constipation at 12 days
It was used to evaluate the symptoms of constipation.
3 secondary outcomes
Constipation Quality of Life Scale (PAC-QOL)
Time frame: Change from baseline constipation-related quality of life at 12 days
Visual Analog Scale (VAS)
Time frame: Change from baseline defecation comfort at 12 days
Number of Defecation
Time frame: Change from baseline number of defecations at 12 days
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 18 Aug 2022.
- Background: PubMed 27903827Shin J, Park H. Effects of Auricular Acupressure on Constipation in Patients With Breast Cancer Receiving Chemotherapy: A Randomized Control Trial. West J Nurs Res. 2018 Jan;40(1):67-83. doi: 10.1177/0193945916680362. Epub 2016 Nov 30.
- Background: PubMed 30675666Wang PM, Hsu CW, Liu CT, Lai TY, Tzeng FL, Huang CF. Effect of acupressure on constipation in patients with advanced cancer. Support Care Cancer. 2019 Sep;27(9):3473-3478. doi: 10.1007/s00520-019-4655-1. Epub 2019 Jan 24.
- Background: PubMed 32379107Jung ES, Chang AK. Effects of Auricular Acupressure in Patients on Hemodialysis. J Nurs Res. 2020 Aug;28(4):e106. doi: 10.1097/jnr.0000000000000378.
- Results publication: PubMed 21531533Lee EJ, Frazier SK. The efficacy of acupressure for symptom management: a systematic review. J Pain Symptom Manage. 2011 Oct;42(4):589-603. doi: 10.1016/j.jpainsymman.2011.01.007. Epub 2011 Apr 30.
- Derived from this study: PubMed 37477804Aydemir T, Tasci S, Bayraktar M, Saz A. The effect of acupressure on constipation symptoms and quality of life among older people: a mixed-methods study. Eur Geriatr Med. 2023 Oct;14(5):1135-1144. doi: 10.1007/s41999-023-00842-6. Epub 2023 Jul 21.
- Individual participant dataSharing planned: Yes. Study Protocol
Related trials for Constıpatıon
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.
Sultan TAŞCI, Prof. Dr. study director
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Constıpatıon, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 18 Aug 2022. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Constipation Assessment Scale (CAS) (time frame: Change from Baseline symptoms of constipation at 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05506397, which also lists 5 linked publications.
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 18 Aug 2022.