NCT05129852

Brief Summary

This study was a randomized controlled trial. It included young girls with primary dysmenorrhea in a district located in the south of Turkey and was conducted between March 01, 2021 and June 30, 2021. The sample size of this research was decided by performing a power analysis in the power statistical program. Considering the parameters of the groups, the effect size was calculated to be 0.5003604. Since α was found to be 0.05 and power (1 - β) was 0.95, a total number of 66 participants were distributed into three equal groups (sage oil massage: 22, Reiki: 22, control: 22). Considering the possibility of case losses, 30 participants were included in each group; finally, a total of 90 people were included in the study. For data collection, a questionnaire regarding sociodemographic characteristics and the visual analog scale (VAS) were used. Reiki and massage with sage oil were applied for 30 minutes, and no application was performed on the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

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

March 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

October 29, 2021

Last Update Submit

November 11, 2021

Conditions

Keywords

midwifery, nurse, alternative therapies

Outcome Measures

Primary Outcomes (3)

  • Individual Introductory Information Form

    Form, information regarding sociodemographic characteristics of the participants was collected.

    2 months

  • VAS pain scores

    Pain levels were scored by the participants using VAS

    2 months

  • Body Mass Index

    Body mass index was calculated by measuring the height and weight of the participants.

    2 months

Study Arms (3)

sage oil group

ACTIVE COMPARATOR

The participants in the sage oil massage group (30 participants in total) had pain in the first 3 days of their menstrual cycle; when the pain started, pain levels were scored by the participants using visual analog scale (VAS). In addition, their blood pressure, body temperature, and pulse rate were measured. The researchers massaged the abdomen with sage oil for 30 minutes, and 30 minutes after the massage, VAS evaluation and blood pressure, body temperature, and pulse rate measurements were performed again. This application was repeated for two menstrual periods.

Other: Sage oil group

Reiki group

ACTIVE COMPARATOR

visual analog scale (VAS) pain scores were also evaluated in the Reiki group (30 participants) when the pain started. The participants experienced pain on the first 3 days of their menstruation. Their blood pressure, body temperature, and pulse rate were also measured. Reiki was applied by a researcher with a Reiki certificate. Thirty minutes after the Reiki application, VAS evaluation and blood pressure, body temperature, and pulse rate measurements were repeated. This application was repeated for two menstrual periods.

Behavioral: Reiki group

control group

NO INTERVENTION

Similarly, in the control group (30 participants),visual analog scale (VAS) pain scores were evaluated when the pain started on the first three days of their menstruation, and their blood pressure, body temperature, and pulse rate were measured. No application was performed; they were only asked to rest. VAS evaluation and blood pressure, body temperature, and pulse rate measurements were performed again after 30 minutes. These measurements were repeated for two menstrual cycles.

Interventions

Sometimes called muscatel. Made by steam or water distillation of Salvia sclarea flowering tops and foliage. Yields range from 0.7 to 1.5%. A pale yellow to yellow liquid with a herbaceous odor and a winelike bouquet. Produced in large quantities in France, Russia and Morocco. The oil contains linalyl acetate, linalool and other terpene alcohols (sclareol), as well as their acetates.

sage oil group
Reiki groupBEHAVIORAL

Within complementary and integrative health practices, Reiki is an ancient practice of Japanese origin widely used worldwide. Through the touch or approximation of the hands, an enabled therapist applies this technique to eliminate toxins, to balance the organism, and to favor the full functioning of the organism, to reestablish the flow of vital energy. Reiki as bioenergy therapy works with the energy that leads the human body to a calmer state that is linked to health and cure. Reiki therapists conduct the curing energy that enters the top of the head and leaves through the hands.

Reiki group

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being female Not married

You may not qualify if:

  • Psychiatric problem Communication barrier Those who refuse to work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nazife Bakir

Burdur, Bucak, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The researchers massaged the abdomen with sage oil for 30 minutes, and 30 minutes after the massage, VAS evaluation and blood pressure, body temperature, and pulse rate measurements were performed again. VAS pain scores were also evaluated in the Reiki group (30 participants) when the pain started. The participants experienced pain on the first 3 days of their menstruation. Their blood pressure, body temperature, and pulse rate were also measured. Reiki was applied by a researcher with a Reiki certificate. Thirty minutes after the Reiki application, VAS evaluation and blood pressure, body temperature, and pulse rate measurements were repeated. This application was repeated for two menstrual periods. Similarly, in the control group (30 participants), VAS pain scores were evaluated when the pain started on the first three days of their menstruation, and their blood pressure, body temperature, and pulse rate were measured. No application was performed; they were only asked to rest.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three groups with alternative therapy is a randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor,

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 22, 2021

Study Start

March 1, 2021

Primary Completion

June 30, 2021

Study Completion

July 10, 2021

Last Updated

November 22, 2021

Record last verified: 2021-11

Locations