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Aromatherapy Massage Applied on Constipation (Aromatherapy)

Primary Purpose

Constipation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aromatherapy Massage
Sponsored by
Ayşe Aydınlı
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Constipation focused on measuring Nurse, Elderly, Constipation, Aromatherapy, Abdominal Massage

Eligibility Criteria

65 Years - 89 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Suleyman Demirel University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

İntervention Group

Control Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2020
Last Updated
August 11, 2020
Sponsor
Ayşe Aydınlı
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1. Study Identification

Unique Protocol Identification Number
NCT04513093
Brief Title
Aromatherapy Massage Applied on Constipation
Acronym
Aromatherapy
Official Title
Effect of Abdominal Massage Applied With Ginger and Lavender Oil on Constipation for Elderly Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 14, 2018 (Actual)
Primary Completion Date
May 21, 2020 (Actual)
Study Completion Date
May 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ayşe Aydınlı

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Nurse, Elderly, Constipation, Aromatherapy, Abdominal Massage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
İntervention Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aromatherapy Massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
1. Mini Mental Test.
Description
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.
Time Frame
Before the application of massage
Title
2. Rome IV Criteria
Description
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.
Time Frame
Before the application of massage
Title
3. Bristol Stool Scale
Description
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.
Time Frame
in four weeks
Title
4. Constipation Severity Scale
Description
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.
Time Frame
in four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Suleyman Demirel University
City
Isparta
ZIP/Postal Code
32100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Aromatherapy Massage Applied on Constipation

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