ConstipationaromatherapyNCT05343910
The Effect of Aroma Massage on Constipation
A study testing Aroma massage in people with Constipation, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Advancing age arising changes in health status and systems adversely affect the quality of life of the elderly and the elderly face many complex health problems. Constipation is one of the common problems in the elderly. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Constipation
- What is being tested?
- Aroma massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2012to 1 Mar 2013
- 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 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years and older
- Communication and cooperation can be established
- Conscious,, agreeing to participate in the research,
- Decreasing bowel movements, not able to deactivate for 3 days or more
- Living more than two of the complaints related to defecation, who have not undergone intestinal surgery before
- Lesion or infection that disrupts skin integrity in the abdominal region, elderly without any problems such as heart disease and dementia
Who cannot join
- had language problems
- were below 65 years of age and
- refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Aroma Massage on Constipation in Elderly
Advancing age arising changes in health status and systems adversely affect the quality of life of the elderly and the elderly face many complex health problems. Constipation is one of the common problems in the elderly. Therefore, The aim of this study is to examine effects of aromatherapy massage on constipation in the elderly.
Read the detailed description
Old age is a physiological period of life in which various changes take place, meaning that the elderly must be given special consideration as a group with regard to health care. Advancing age arising changes in health status and systems adversely affect the quality of life of the elderly and the elderly face many complex health problems. Constipation is one of the common problems in the elderly. Insufficient liquid intake, insufficient or unsuitable diet, decreased mobility, the side effects of medication, underlying diseases, and rectal sensory-motor dysfunction are among the causes of constipation in the elderly. Constipation is a preventable and treatable problem, which if left untreated can cause physical and associated psychological problems such as back and waist pain, rectal pressure, loss of appetite, confusion, incontinence, nausea and vomiting, urinary dysfunction, fissure, rectal prolapse, hemorrhoids, intestinal obstruction, and syncope. Constipation can be managed using pharmacological methods, such as laxatives, enemas, suppositories, along with nonpharmacological procedures, such as changes in nutritional habits, fluid intake, education, activities to develop healthy intestinal habits, exercise, massage, aroma massage, biofeedback, stress management and acupuncture.
- Conditions
- Constipation
- Being tested
- Aroma massage
- Keywords
- aroma massage, constipation, elderly, nursing
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aroma massageOther
The older adult participants in the experimental group were applied aroma massage through gentle movements with slight pressure for 15 min a day, five days a week for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy massage group | Experimental | Experimental: aromatherapy massage group The oil mixture used in this study (1:, 1:, 1: 1, 20cc rosemary, 20cc mint, 20cc ginger, 20cc black pepper), 80% of the mixture obtained from the total 4% (3.2cc) carrier oil (100% almond oil=96.8cc) and then combined with abdominal massage. Before implementing the procedure in the experimental group (n=25), information about what an abdominal and aroma massage is, how long it will take, and how it will be applied was provided to the participants. The older adult participants in the experimental group were applied aroma massage through gentle movements with slight pressure for 15 min a day, five days a week for three weeks. Receives: Other: Aroma massage |
| Control group | No intervention | Individuals in the control group (n=24) did not receive any type of aroma massage application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool consistency
Small as marble, hard (1 point) Bulky, hard (2 points) Normal (3 points) Soft (4 points) Juicy (5 points)
7-day total value for stool consistency / 7-day total number of stools
Measured: change from before intervention, 3rd and 4th week of intervention
Amount of stool
None (0 points) Less than the previous stool (1 point) Normal (2 points) a lot (3 points) 7-day total value for stool amount / 7-day total number of stools
Measured: change from before intervention, 3rd and 4th week of intervention
Straining during defecation
Defecation without straining (1 point) Straining at the beginning of defecation (2 points) Straining at half defecation (3 points) Straining during the entire defecation (4 points)
Obtained 7 days for straining during defecation total value / total number of defecations in 7 days
Measured: change from before intervention, 3rd and 4th week of intervention
38 / 5.000 Çeviri sonuçları Full after defecation feeling of inability to ejaculate
None after defecation (0 points) Present after defecation (1 point)
7 for the feeling of incomplete ejaculation after defecation. total value obtained per day / total number of defecations in 7 days
Measured: change from before intervention, 3rd and 4th week of intervention
Number of defecations
How many defecations per day
Total number of defecations in 7 days / 7
Measured: change from before intervention, 3rd and 4th week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Dec 2012
- Primary completion1 Mar 2013
- Study completion1 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Lafci, Mersin University
- Investigators
- Mağfiret Kaşıkçı, Prof., Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343910
- Sponsor's protocol ID
- MersinUniversty
- Acronym
- aromatherapy
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aroma Massage on Constipation in Elderly
- ClinicalTrials.gov ID
- NCT05343910
- Acronym / sponsor ID
- aromatherapy / MersinUniversty
- Conditions
- Constipation
- Keywords
- aroma massage, constipation, elderly, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 1 Mar 2013 (actual)
- Study completion
- 1 Mar 2013 (actual)
- First posted
- 25 Apr 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.
Advancing age arising changes in health status and systems adversely affect the quality of life of the elderly and the elderly face many complex health problems. Constipation is one of the common problems in the elderly. Therefore, The aim of this study is to examine effects of aromatherapy massage on constipation in the elderly.
Detailed description
Old age is a physiological period of life in which various changes take place, meaning that the elderly must be given special consideration as a group with regard to health care. Advancing age arising changes in health status and systems adversely affect the quality of life of the elderly and the elderly face many complex health problems. Constipation is one of the common problems in the elderly. Insufficient liquid intake, insufficient or unsuitable diet, decreased mobility, the side effects of medication, underlying diseases, and rectal sensory-motor dysfunction are among the causes of constipation in the elderly. Constipation is a preventable and treatable problem, which if left untreated can cause physical and associated psychological problems such as back and waist pain, rectal pressure, loss of appetite, confusion, incontinence, nausea and vomiting, urinary dysfunction, fissure, rectal prolapse, hemorrhoids, intestinal obstruction, and syncope. Constipation can be managed using pharmacological methods, such as laxatives, enemas, suppositories, along with nonpharmacological procedures, such as changes in nutritional habits, fluid intake, education, activities to develop healthy intestinal habits, exercise, massage, aroma massage, biofeedback, stress management and acupuncture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy massage group | Experimental | Other: Aroma massageExperimental: aromatherapy massage group The oil mixture used in this study (1:, 1:, 1: 1, 20cc rosemary, 20cc mint, 20cc ginger, 20cc black pepper), 80% of the mixture obtained from the total 4% (3.2cc) carrier oil (100% almond oil=96.8cc) and then combined with abdominal massage. Before implementing the procedure in the experimental group (n=25), information about what an abdominal and aroma massage is, how long it will take, and how it will be applied was provided to the participants. The older adult participants in the experimental group were applied aroma massage through gentle movements with slight pressure for 15 min a day, five days a week for three weeks. |
| Control group | No intervention | –Individuals in the control group (n=24) did not receive any type of aroma massage application. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 65 years and older
- Communication and cooperation can be established
- Conscious,, agreeing to participate in the research,
- Decreasing bowel movements, not able to deactivate for 3 days or more
- Living more than two of the complaints related to defecation, who have not undergone intestinal surgery before
Key exclusion criteria (3 listed)
- had language problems
- were below 65 years of age and
- refused to participate in the study.
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 |
|---|---|---|
| Aroma massageThe older adult participants in the experimental group were applied aroma massage through gentle movements with slight pressure for 15 min a day, five days a week for three weeks. | Other | Aromatherapy massage group |
Primary outcome
Stool consistency
Time frame: change from before intervention, 3rd and 4th week of intervention
Small as marble, hard (1 point) Bulky, hard (2 points) Normal (3 points) Soft (4 points) Juicy (5 points) 7-day total value for stool consistency / 7-day total number of stools
Amount of stool
Time frame: change from before intervention, 3rd and 4th week of intervention
None (0 points) Less than the previous stool (1 point) Normal (2 points) a lot (3 points) 7-day total value for stool amount / 7-day total number of stools
Straining during defecation
Time frame: change from before intervention, 3rd and 4th week of intervention
Defecation without straining (1 point) Straining at the beginning of defecation (2 points) Straining at half defecation (3 points) Straining during the entire defecation (4 points) Obtained 7 days for straining during defecation total value / total number of defecations in 7 days
38 / 5.000 Çeviri sonuçları Full after defecation feeling of inability to ejaculate
Time frame: change from before intervention, 3rd and 4th week of intervention
None after defecation (0 points) Present after defecation (1 point) 7 for the feeling of incomplete ejaculation after defecation. total value obtained per day / total number of defecations in 7 days
Number of defecations
Time frame: change from before intervention, 3rd and 4th week of intervention
How many defecations per day Total number of defecations in 7 days / 7
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 25 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Mağfiret Kaşıkçı, Prof. study director
Ataturk 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 Aroma massage in people with Constipation, run by Mersin 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 6 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 25 Apr 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. 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?
Stool consistency (time frame: change from before intervention, 3rd and 4th week of intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2022.