Health TrialsbyHealthPanel

Primary Dysmenorrhea and Comfort Theory

ConditionPrimary Dysmenorrhea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOrdu University

About this trial

Dysmenorrhea is defined as lower abdominal pain experienced during menstruation. It is divided into two types: primary dysmenorrhea and secondary dysmenorrhea. In young women, the majority of dysmenorrhea cases are primary dysmenorrhea. Primary dysmenorrhea has a physical, psychological, and social impact on young women. Pharmacological and non-pharmacological methods are used to treat primary dysmenorrhea. Education is important in increasing the effectiveness of primary dysmenorrhea treatment. An effective education process takes place in accordance with nursing theories and models. There are a limited number of studies on the effect of comfort theory-based education in the management of primary dysmenorrhea. In this research, planned as a randomized controlled trial, the intervention group will receive comfort theory-based education, while the control group will receive no intervention. This study aims to contribute to the literature by investigating the effect of comfort theory-based education on dysmenorrhea, menstrual symptoms, premenstrual syndrome, and general well-being in university students with primary dysmenorrhea.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female students aged 18 and over

Single

Having a menstrual pain intensity of 3 or higher according to the Visual Analog Scale

Having had a regular menstrual cycle for the last 6 months

Disqualifiers

Women diagnosed with a psychiatric illness

Women diagnosed with a gynecological illness

Women diagnosed with a chronic illness

Women using a pharmacological or non-pharmacological method for primary dysmenorrhea

Trial design

Design model

Parallel

Treatments tested in this trial

  • Comfort Theory-Based Education

    Other intervention

    The training program will be conducted face-to-face and through oral instruction. Each training session will last 40 minutes. A total of three training sessions will be given, one per month, over a three-month period.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: intervention groupActive comparator 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Visual Analog Scale

On a scale consisting of a ruler, one end is marked "0" (the point where there is no pain) and the other end is marked "10" (the point where the pain is most severe). Pain levels are classified as follows: less than 3 is mild, 3-6 is moderate, and more than 6 is severe.

Time frame
three months

Secondary outcomes

1

Menstruation Symptom Scale

This scale consists of 22 items. Participants are asked to rate their menstrual symptoms on a scale of 1 (never) to 5 (always). The lowest score on the scale is 22, and the highest score is 110. A higher score indicates an increase in the severity of menstrual symptoms.

Time frame
three months
2

Dysmenorrhea Impact Scale

This scale consists of 13 items. Participants are asked to rate each item on a scale of 1 to 5. The lowest score on the scale is 13, and the highest score is 65. As participants' scores on the scale increase, their level of being affected by dysmenorrhea also increases.

Time frame
three months
3

Premenstrual Syndrome Scale

This scale consists of 44 items. Participants are asked to rate each item on a scale of 1 to 5. The lowest score is 44, and the highest score is 220. Higher scores indicate a higher severity of premenstrual syndrome

Time frame
three months
4

General Well-being Scale

This scale consists of 14 items. Participants are asked to rate each item on a scale of 1 to 5. The lowest score on the scale is 14, and the highest score is 70. As participants' scores on the scale increased, their overall level of well-being also increased.

Time frame
three months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ordu University

Lead sponsor

Ordu University Scientific Research Projects Coordination Department

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: