Primary Dysmenorrhea Clinical Trial
Official title:
The Effect of Connective Tissue Manipulation on General Health and Emotional Status in Women With Primary Dysmenorrhea: Long-Term Follow-Up
NCT number | NCT04509934 |
Other study ID # | 12 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 30, 2018 |
Est. completion date | March 30, 2020 |
Verified date | August 2020 |
Source | Istanbul University-Cerrahpasa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study was to reveal the effects of connective tissue manipulation (CTM) on pain severity, fatigue, sleep quality, general health status, systemic symptoms, anxiety and depression in women with primary dysmenorrhoea and to determine the effect of treatment time on recovery in a longterm period. Our primary outcome was intensity of menstrual pain. Secondary outcomes were intensity of sleep disturbance, fatigue, depression and anxiety status, general health and premenstrual symptoms.
Status | Completed |
Enrollment | 39 |
Est. completion date | March 30, 2020 |
Est. primary completion date | March 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Being in a age range 18-30 - Diagnosed with Primary Dysmenorrhea by a gynecologist - Having a regular menstrual cycle (28±7 days) - Being nulliparous - Having menstrual pain intensity above 5cm according to Visual Analog Scale Exclusion Criteria: - Having gastrointestinal, urogynecologic, or psychiatric disease, other chronic pain syndromes - Having a positive pregnancy test - History of pelvic surgery - Usage of oral contraceptives or antidepressants for at least 3 months - Having irregular menstrual cycles (defined as lasting<21or>35 days) - Having a history or an ultrasonographic observation of pathological conditions indicating secondary dysmenorrhea |
Country | Name | City | State |
---|---|---|---|
Turkey | Pamukkale University | Denizli |
Lead Sponsor | Collaborator |
---|---|
Istanbul University-Cerrahpasa | Pamukkale University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analogue Scale | Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain." | baseline (first assessment) and 3th, 6th and 12th months after treatment | |
Primary | Visual Analogue Scale | Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain." | 3th month after treatment | |
Primary | Visual Analogue Scale | Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain." | 6th month after treatment | |
Primary | Visual Analogue Scale | Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain." | 12th month after treatment | |
Secondary | Visual Analogue Scale | Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance." | baseline (first assessment) | |
Secondary | Visual Analogue Scale | Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance." | 3th month after treatment | |
Secondary | Visual Analogue Scale | Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance." | 6th month after treatment | |
Secondary | Visual Analogue Scale | Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance." | 12th month after treatment | |
Secondary | Visual Analogue Scale | Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue. | baseline (first assessment) | |
Secondary | Visual Analogue Scale | Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue. | 3th month after treatment | |
Secondary | Visual Analogue Scale | Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue. | 6th month after treatment | |
Secondary | Visual Analogue Scale | Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue. | 12th month after treatment | |
Secondary | Beck Depression Inventory | Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms | baseline (first assessment) | |
Secondary | Beck Depression Inventory | Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms | 3th month after treatment | |
Secondary | Beck Depression Inventory | Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms | 6th month after treatment | |
Secondary | Beck Depression Inventory | Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms | 12th month after treatment | |
Secondary | Beck Anxiety Inventory | Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety. | baseline (first assessment) | |
Secondary | Beck Anxiety Inventory | Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety. | 3th month after treatment | |
Secondary | Beck Anxiety Inventory | Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety. | 6th month after treatment | |
Secondary | Beck Anxiety Inventory | Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety. | 12th month after treatment | |
Secondary | General Health Questionnaire | General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms. | baseline (first assessment) | |
Secondary | General Health Questionnaire | General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms. | 3th month after treatment | |
Secondary | General Health Questionnaire | General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms. | 6th month after treatment | |
Secondary | General Health Questionnaire | General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms. | 12th month after treatment | |
Secondary | Premenstrual Syndrome Scale | Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms. | baseline (first assessment) | |
Secondary | Premenstrual Syndrome Scale | Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms. | 3th month after treatment | |
Secondary | Premenstrual Syndrome Scale | Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms. | 6th month after treatment | |
Secondary | Premenstrual Syndrome Scale | Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms. | 12th month after treatment |
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