ConstipationAromatherapyNCT04513093
Aromatherapy Massage Applied on Constipation
A study testing Aromatherapy Massage in people with Constipation, run by Ayşe Aydınlı at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study was conducted as a randomized controlled experimental study to examine the effect of abdominal massage with ginger and lavender oil on constipation in elderly individuals. Read more about this study
- Who is it for?
- Ages 65 to 89 years
- Conditions the study is for
- Constipation
- What is being tested?
- Aromatherapy Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jan 2018to 21 May 2020
- 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 89 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly individuals with constipation determined by the institution doctor,
- Individuals diagnosed with constipation according to the Roma-criteria,
- Individuals, who achieved a score of 24 and higher on the standardized mini mental test (SMMT),
- Individuals, who do not have lesions disrupting skin integrity in the abdominal region,
- And elderly individuals, who agreed to participate in the study were included.
Who cannot join
- Individuals diagnosed with irritable bowel syndrome (IBS),
- Individuals who have undergone bowel surgery before,
- Individuals diagnosed with colon cancer,
- Individuals with percutaneous endoscopic gastrostomy,
- Individuals with umbilical hernia
- And individuals allergic to lavender and ginger oil.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Abdominal Massage Applied With Ginger and Lavender Oil on Constipation for Elderly Individuals
Aim: This study was conducted as a randomized controlled experimental study to examine the effect of abdominal massage with ginger and lavender oil on constipation in elderly individuals.
Design: The study was completed with 40 elderly individuals in Kayseri nursing home, including 20 in intervention and 20 in control group who met the criteria for inclusion in the study. In the study, written informed volunteer consent was obtained from the individuals with the approval of the ethics committee and the permission of the institution.
The elderly individuals in the intervention group underwent aromatherapy massage with ginger and lavender oils for a period of five days and 15 minutes on weekdays for four weeks according to the abdominal massage application protocol. No application was made to individuals in the control group.
Read the detailed description
Aim: This study was conducted as a randomized controlled experimental study to examine the effect of abdominal massage with ginger and lavender oil on constipation in elderly individuals.
Design: The study was completed with 40 elderly individuals in Kayseri nursing home, including 20 in intervention and 20 in control group who met the criteria for inclusion in the study. In the study, written informed volunteer consent was obtained from the individuals with the approval of the ethics committee and the permission of the institution. The data were collected by the researcher using the Questionnaire Form, Bristol Stool Scale, Rome IV Criteria, Constipation Severity Scale and Mini Mental Test.
The elderly individuals in the intervention group underwent aromatherapy massage with ginger and lavender oils for a period of five days and 15 minutes on weekdays for four weeks according to the abdominal massage application protocol. No application was made to individuals in the control group. The "Bristol Stool Scale" and "Constipation Severity Scale" were re-applied to the individuals in the intervention and control group before, during the second week of practice and at the end of practice (fourth week).
- Conditions
- Constipation
- Being tested
- Aromatherapy Massage
- Keywords
- Nurse, Elderly, Constipation, Aromatherapy, Abdominal Massage
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy MassageOther
The elderly individuals in the intervention group underwent aromatherapy massage with ginger and lavender oils for a period of five days and 15 minutes on weekdays for four weeks according to the abdominal massage application protocol.
| Study group | Role | What they receive |
|---|---|---|
| İntervention Group | Experimental | The elderly individuals in the intervention group underwent aromatherapy massage with ginger and lavender oils for a period of five days and 15 minutes on weekdays for four weeks according to the abdominal massage application protocol.
The "Bristol Stool Scale" and "Constipation Severity Scale" were re-applied to the individuals in the intervention before, during the second week of practice and at the end of practice (fourth week). Receives: Other: Aromatherapy Massage |
| Control Group | No intervention | No application was applied to the individuals in the control group. "Bristol Stool Scale" and "Constipation Severity Scale" were applied to the individuals in the control group at the same time as (at the beginning, second week and fourth week) the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Mini Mental Test.
The mini mental test was first developed by Folstein et al. in 1975 to assess cognitive functions. The SMMT consists of five categories, which are orientation, attention and calculation, recall, registration and language. The maximum total score is 30 points. A score higher than 18/19 is considered as good cognitive state for uneducated individuals and a score of 23/34 for educated individuals. The scale was filled out by the researcher before the application by interviewing the elderly participants face to face, who were diagnosed with constipation and agreed to participate in the study.
Measured: Before the application of massage
2. Rome IV Criteria
In this study the diagnosis of constipation was made with the Rome IV criteria. The Rome IV criteria are; straining, lumpy or hard stool, feeling of incomplete emptying, feeling of anorectal obstruction, need for manual intervention, fewer than three defecations per week and rare occurrence of soft stool without laxatives in at least 25% of defecations and insufficient criteria for irritable bowel syndrome. If at least 2 of these symptoms are present and if these symptoms have begun at least 6 months prior or have been lasting for the last three months leads to the diagnosis of constipation.
Measured: Before the application of massage
3. Bristol Stool Scale
The Bristol Stool Scale was developed by Lewis and Heaton at Bristol University in the United Kingdom. The Bristol Stool Scale provides information about the duration of stool in the colon and its changing physical characteristics during this period and divides the stool types into seven different categories. Type 1 and type 2 describe constipation, type 2, type 4 and type 5 normal stool shapes and type 6 and type 7 diarrhea. The constipation status of the individuals was evaluated with the Bristol Stool Scale three times in total, before the application and in the second and fourth weeks of the application.
Measured: in four weeks
4. Constipation Severity Scale
The Constipation Severity Scale (CSS) consists of 16 questions to determine the frequency of defecation of individuals and the difficulty and pain experienced during defecation. The CSS has three subscales; Obstructive Defecation Subscale (ODSS), Lazy Bowel Subscale (LBSS) and Pain Subscale (PSS). The minimum total score of the CSS is 0 and the maximum score is 73. As the total scale score increases the level of symptoms also increases. In the study, the constipation status of the elderly individuals was evaluated three times in total, before the application and in the second and fourth weeks of the application.
Measured: in four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start14 Jan 2018
- Primary completion21 May 2020
- Study completion21 May 2020
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.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayşe Aydınlı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayşe Aydınlı, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513093
- Sponsor's protocol ID
- SuleymanDU Aaydinli
- Acronym
- Aromatherapy
- Status last verified
- Aug 2020
- First submitted
- 9 Aug 2020
- Last updated
- 14 Aug 2020
- 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 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Abdominal Massage Applied With Ginger and Lavender Oil on Constipation for Elderly Individuals
- ClinicalTrials.gov ID
- NCT04513093
- Acronym / sponsor ID
- Aromatherapy / SuleymanDU Aaydinli
- Conditions
- Constipation
- Keywords
- Nurse, Elderly, Constipation, Aromatherapy, Abdominal Massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ayşe AydınlıUniversity, hospital or other
- Study start
- 14 Jan 2018 (actual)
- Primary completion
- 21 May 2020 (actual)
- Study completion
- 21 May 2020 (actual)
- First posted
- 14 Aug 2020 (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.
Aim: This study was conducted as a randomized controlled experimental study to examine the effect of abdominal massage with ginger and lavender oil on constipation in elderly individuals.
Design: The study was completed with 40 elderly individuals in Kayseri nursing home, including 20 in intervention and 20 in control group who met the criteria for inclusion in the study. In the study, written informed volunteer consent was obtained from the individuals with the approval of the ethics committee and the permission of the institution.
The elderly individuals in the intervention group underwent aromatherapy massage with ginger and lavender oils for a period of five days and 15 minutes on weekdays for four weeks according to the abdominal massage application protocol. No application was made to individuals in the control group.
Detailed description
Aim: This study was conducted as a randomized controlled experimental study to examine the effect of abdominal massage with ginger and lavender oil on constipation in elderly individuals.
Design: The study was completed with 40 elderly individuals in Kayseri nursing home, including 20 in intervention and 20 in control group who met the criteria for inclusion in the study. In the study, written informed volunteer consent was obtained from the individuals with the approval of the ethics committee and the permission of the institution. The data were collected by the researcher using the Questionnaire Form, Bristol Stool Scale, Rome IV Criteria, Constipation Severity Scale and Mini Mental Test.
The elderly individuals in the intervention group underwent aromatherapy massage with ginger and lavender oils for a period of five days and 15 minutes on weekdays for four weeks according to the abdominal massage application protocol. No application was made to individuals in the control group. The "Bristol Stool Scale" and "Constipation Severity Scale" were re-applied to the individuals in the intervention and control group before, during the second week of practice and at the end of practice (fourth week).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention Group | Experimental | Other: Aromatherapy MassageThe elderly individuals in the intervention group underwent aromatherapy massage with ginger and lavender oils for a period of five days and 15 minutes on weekdays for four weeks according to the abdominal massage application protocol. The "Bristol Stool Scale" and "Constipation Severity Scale" were re-applied to the individuals in the intervention before, during the second week of practice and at the end of practice (fourth week). |
| Control Group | No intervention | –No application was applied to the individuals in the control group. "Bristol Stool Scale" and "Constipation Severity Scale" were applied to the individuals in the control group at the same time as (at the beginning, second week and fourth week) the intervention group. |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Elderly individuals with constipation determined by the institution doctor,
- Individuals diagnosed with constipation according to the Roma-criteria,
- Individuals, who achieved a score of 24 and higher on the standardized mini mental test (SMMT),
- Individuals, who do not have lesions disrupting skin integrity in the abdominal region,
- And elderly individuals, who agreed to participate in the study were included.
Key exclusion criteria (6 listed)
- Individuals diagnosed with irritable bowel syndrome (IBS),
- Individuals who have undergone bowel surgery before,
- Individuals diagnosed with colon cancer,
- Individuals with percutaneous endoscopic gastrostomy,
- Individuals with umbilical hernia
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 |
|---|---|---|
| Aromatherapy MassageThe elderly individuals in the intervention group underwent aromatherapy massage with ginger and lavender oils for a period of five days and 15 minutes on weekdays for four weeks according to the abdominal massage application protocol. | Other | İntervention Group |
Primary outcome
1. Mini Mental Test.
Time frame: Before the application of massage
The mini mental test was first developed by Folstein et al. in 1975 to assess cognitive functions. The SMMT consists of five categories, which are orientation, attention and calculation, recall, registration and language. The maximum total score is 30 points. A score higher than 18/19 is considered as good cognitive state for uneducated individuals and a score of 23/34 for educated individuals. The scale was filled out by the researcher before the application by interviewing the elderly participants face to face, who were diagnosed with constipation and agreed to participate in the study.
2. Rome IV Criteria
Time frame: Before the application of massage
In this study the diagnosis of constipation was made with the Rome IV criteria. The Rome IV criteria are; straining, lumpy or hard stool, feeling of incomplete emptying, feeling of anorectal obstruction, need for manual intervention, fewer than three defecations per week and rare occurrence of soft stool without laxatives in at least 25% of defecations and insufficient criteria for irritable bowel syndrome. If at least 2 of these symptoms are present and if these symptoms have begun at least 6 months prior or have been lasting for the last three months leads to the diagnosis of constipation.
3. Bristol Stool Scale
Time frame: in four weeks
The Bristol Stool Scale was developed by Lewis and Heaton at Bristol University in the United Kingdom. The Bristol Stool Scale provides information about the duration of stool in the colon and its changing physical characteristics during this period and divides the stool types into seven different categories. Type 1 and type 2 describe constipation, type 2, type 4 and type 5 normal stool shapes and type 6 and type 7 diarrhea. The constipation status of the individuals was evaluated with the Bristol Stool Scale three times in total, before the application and in the second and fourth weeks of the application.
4. Constipation Severity Scale
Time frame: in four weeks
The Constipation Severity Scale (CSS) consists of 16 questions to determine the frequency of defecation of individuals and the difficulty and pain experienced during defecation. The CSS has three subscales; Obstructive Defecation Subscale (ODSS), Lazy Bowel Subscale (LBSS) and Pain Subscale (PSS). The minimum total score of the CSS is 0 and the maximum score is 73. As the total scale score increases the level of symptoms also increases. In the study, the constipation status of the elderly individuals was evaluated three times in total, before the application and in the second and fourth weeks of the application.
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 14 Aug 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy Massage in people with Constipation, run by Ayşe Aydınlı 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 5 inclusion and 6 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 14 Aug 2020. 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?
1. Mini Mental Test. (time frame: Before the application of massage). The study lists 4 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 14 Aug 2020.