NCT05343910

Brief 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. Therefore, The aim of this study is to examine effects of aromatherapy massage on constipation in the elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 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

December 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

March 23, 2022

Last Update Submit

April 19, 2022

Conditions

Constipation

Keywords

aroma massageconstipationelderlynursing

Outcome Measures

Primary Outcomes (5)

  • 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

    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

    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

    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

    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

    change from before intervention, 3rd and 4th week of intervention

Study Arms (2)

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.

Other: Aroma massage

Control group

NO INTERVENTION

Individuals in the control group (n=24) did not receive any type of aroma massage application.

Interventions

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.

Aromatherapy massage group

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • had language problems
  • were below 65 years of age and
  • refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University

Mersin, 33110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mağfiret Kaşıkçı, Prof.

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2022

First Posted

April 25, 2022

Study Start

December 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)