NCT04513093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

2.4 years

First QC Date

August 9, 2020

Last Update Submit

August 11, 2020

Conditions

Keywords

NurseElderlyConstipationAromatherapyAbdominal Massage

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    in four weeks

Study Arms (2)

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).

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.

Interventions

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.

İntervention Group

Eligibility Criteria

Age65 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Demirel University

Isparta, 32100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Research Asistant

Study Record Dates

First Submitted

August 9, 2020

First Posted

August 14, 2020

Study Start

January 14, 2018

Primary Completion

May 21, 2020

Study Completion

May 21, 2020

Last Updated

August 14, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations