- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07563426
The Effect of Spinal Stabilization Training in Women With Dysmenorrhea
The Effect of Spinal Stabilization Training in Women With Dysmenorrhea: A Randomized Controlled Trial
The study, designed as a randomized controlled experimental trial, was conducted at Tonya Vocational School. Institutional approval was obtained to carry out the study at Tonya Vocational School (Appendix-). Participants who met the inclusion and exclusion criteria and voluntarily agreed to participate were required to sign an informed consent form prior to the initiation of the study. Following the acquisition of informed consent, 50 women with dysmenorrhea, identified based on the WaLIDD score, were randomly allocated into two groups using a simple randomization method (sealed envelope): 25 participants in the experimental group and 25 in the control group.Baseline assessments were performed by the same researcher within the first week immediately following the most recent menstrual period, prior to the commencement of the intervention. Participants' demographic characteristics and menstrual cycle information were recorded using a data collection form before the exercise intervention.
Pain intensity was evaluated using the Visual Analog Scale (VAS); menstrual symptom severity using the Menstrual Symptom Scale; body awareness using the Body Awareness Questionnaire; muscle endurance using the McGill trunk endurance tests; lumbopelvic mobility using the Modified Schober test; activities of daily living using the Lawton-Brody Instrumental Activities of Daily Living Scale; problem-solving skills using the Problem Solving Inventory; decision-making styles using the Melbourne Decision Making Questionnaire; quality of life using the SF-12 questionnaire; and physical activity levels using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). All measurements were conducted within the first week immediately following the most recent menstrual period, both before (baseline assessment) and after (post-intervention assessment) the exercise program.
Study Overview
Status
Intervention / Treatment
Detailed Description
The study, designed as a randomized controlled experimental trial, was conducted at Tonya Vocational School. Institutional approval was obtained to carry out the study at Tonya Vocational School (Appendix-). Participants who met the inclusion and exclusion criteria and voluntarily agreed to participate were required to sign an informed consent form prior to the initiation of the study. Following the acquisition of informed consent, 50 women with dysmenorrhea, identified based on the WaLIDD score, were randomly allocated into two groups using a simple randomization method (sealed envelope): 25 participants in the experimental group and 25 in the control group.Baseline assessments were performed by the same researcher within the first week immediately following the most recent menstrual period, prior to the commencement of the intervention. Participants' demographic characteristics and menstrual cycle information were recorded using a data collection form before the exercise intervention.
Pain intensity was evaluated using the Visual Analog Scale (VAS); menstrual symptom severity using the Menstrual Symptom Scale; body awareness using the Body Awareness Questionnaire; muscle endurance using the McGill trunk endurance tests; lumbopelvic mobility using the Modified Schober test; activities of daily living using the Lawton-Brody Instrumental Activities of Daily Living Scale; problem-solving skills using the Problem Solving Inventory; decision-making styles using the Melbourne Decision Making Questionnaire; quality of life using the SF-12 questionnaire; and physical activity levels using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). All measurements were conducted within the first week immediately following the most recent menstrual period, both before (baseline assessment) and after (post-intervention assessment) the exercise program.
The control group was provided with relaxation exercises and lifestyle recommendations, including avoidance of exposure to environmental tobacco smoke; reduction or cessation of smoking and alcohol consumption; limitation of the intake of caffeine, sugar, cold foods and beverages, and high-salt foods; preference for loose and cotton clothing; taking warm standing showers; and maintaining adequate and good-quality sleep (at least 6-8 hours). These recommendations were delivered to the control group .In addition to relaxation exercises and lifestyle recommendations, the experimental group received spinal stabilization training. A total of 16 sessions of spinal stabilization training were administered under the supervision of a physiotherapist, with two sessions per week over an 8-week period. Each session lasted approximately 45-50 minutes. The exercise program began with a 5-6 minute warm-up, followed by a 35-40 minute main program, and concluded with a 5-6 minute cool-down period. The warm-up and cool-down phases consisted of general stretching exercises and light jogging.The exercise program was designed to be progressive; accordingly, during the first week, participants performed a single set of 6-10 repetitions for each exercise. The number of repetitions and sets was increased every two weeks based on the participants' capacity. Progression in the exercise program was achieved by increasing the number of repetitions and sets, adding resistance, and extending the duration. The level of exertion was determined using the Borg Scale (6-20), and the exercise intensity was increased when participants reached a Borg rating of 11-14.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Izmir, Turkey (Türkiye)
- Izmir Katip Celebi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between 18 and 30 years of age
- Having no history of childbirth
- Being cooperative and oriented
- Having a regular menstrual cycle (28 ± 7 days)
- Scoring >1 on the WaLIDD scale
- Reporting a menstrual pain score greater than 4 out of 10 on the Visual 7)Analog Scale (VAS)
8)Volunteering to participate in the study
Exclusion Criteria:
- Using hormonal contraceptive medications or an intrauterine device (IUD)
- Having any mental, cardiovascular, pulmonary, or orthopedic condition that could limit exercise participation
- Being pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Spinal Stabilization Exercise Group
In addition to relaxation exercises and lifestyle recommendations, the experimental group received spinal stabilization training .
Under the supervision of a physiotherapist, spinal stabilization exercises were performed twice weekly for eight weeks, with session durations of 30 minutes in the initial weeks and 45-55 minutes in the subsequent weeks.
Each session consisted of a 5-minute warm-up (walking and stretching exercises), 30-40 minutes of spinal stabilization exercises in the early weeks and 45-55 minutes in the later weeks, and a 5-minute cool-down period (stretching exercises) (12).The progression of the exercises was individualized according to each patient's ability, fatigue level, and pain response.
The level of exertion was determined using the Borg Scale (6-20), and the exercise intensity was increased when participants reached a Borg score of 11-14 (13).
|
In addition to relaxation exercises and lifestyle recommendations, the experimental group received spinal stabilization training .
Under the supervision of a physiotherapist, spinal stabilization exercises were performed twice weekly for eight weeks, with session durations of 30 minutes in the initial weeks and 45-55 minutes in the subsequent weeks.
Each session consisted of a 5-minute warm-up (walking and stretching exercises), 30-40 minutes of spinal stabilization exercises in the early weeks and 45-55 minutes in the later weeks, and a 5-minute cool-down period (stretching exercises) (12).The progression of the exercises was individualized according to each patient's ability, fatigue level, and pain response.
The level of exertion was determined using the Borg Scale (6-20), and the exercise intensity was increased when participants reached a Borg score of 11-14 (13).
|
|
Active Comparator: Active Comparator: Relaxation exercise group
The control group will be provided with relaxation exercises and lifestyle recommendations. After the relaxation exercises are explained by a physiotherapist, lifestyle recommendations for participants will include avoidance of exposure to environmental tobacco smoke; reduction or cessation of smoking and alcohol consumption; limitation of caffeine, sugar, cold foods and beverages, and foods with high salt content; use of loose and cotton clothing; warm standing showers; and adequate and good-quality sleep (at least 6-8 hours) (9,10). To facilitate adherence and support the follow-up of relaxation training, a brochure was prepared and provided to the participants. Participants will perform relaxation exercises once per week for 8 weeks, with each session lasting 30 minutes (1). |
The control group will be provided with relaxation exercises and lifestyle recommendations. After the relaxation exercises are explained by a physiotherapist, lifestyle recommendations for participants will include avoidance of exposure to environmental tobacco smoke; reduction or cessation of smoking and alcohol consumption; limitation of caffeine, sugar, cold foods and beverages, and foods with high salt content; use of loose and cotton clothing; warm standing showers; and adequate and good-quality sleep (at least 6-8 hours) (9,10). To facilitate adherence and support the follow-up of relaxation training, a brochure was prepared and provided to the participants. Participants will perform relaxation exercises once per week for 8 weeks, with each session lasting 30 minutes (1). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS):
Time Frame: "Baseline and Week 8
|
Pain intensity was assessed using the VAS.
Participants indicated the severity of pain by marking an "x" on a 10-cm line, with each centimeter representing one unit.
A score of "0" indicated no pain, while a score of "10" represented the most severe pain.
|
"Baseline and Week 8
|
|
Menstruation Symptom Scale
Time Frame: "Baseline and Week 8
|
This scale was used to evaluate menstrual symptoms.
The questionnaire consists of 22 items, including 19 items assessing symptoms (emotional, physical, and pain-related) and 3 items evaluating coping strategies for symptoms.
Higher total scores indicate more severe menstrual symptoms.
The Turkish validity and reliability study of the scale was conducted by Gülten Güvenç.Minimum score: 22, Maximum score:110.
|
"Baseline and Week 8
|
|
McGill Trunk Endurance Tests:
Time Frame: Baseline and Week 8
|
Lumbopelvic muscle endurance was assessed using the McGill trunk endurance tests , which include trunk flexion, extension, and lateral flexion (right and left) endurance assessments. The testing positions were demonstrated and explained to participants in advance. Participants were then asked to repeat each position once to familiarize themselves with the assessment postures. Participants were encouraged to maintain each isometric position for as long as possible for each test. The duration for which individuals were able to maintain the correct posture was recorded in seconds . The McGill trunk endurance tests were terminated when the test position deteriorated or when participants indicated that they could no longer continue the test. |
Baseline and Week 8
|
|
Modified Schober Test:
Time Frame: Baseline and Week 8
|
This test was used to assess lumbopelvic mobility.
It is a method that measures lumbar spinal mobility during flexion and extension movements .
For the measurement, the line between both posterior superior iliac spines was first marked, and points 10 cm above and 5 cm below this mark were identified.
Participants were then asked to bend forward.
The difference between the initial and final measurements was recorded in centimeters.
In this test, a 0-5 cm difference indicates reduced flexion flexibility, a difference greater than 10 cm indicates increased flexibility, and values between 5-10 cm are considered normal.
|
Baseline and Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Problem Solving Inventory:
Time Frame: Baseline and Week 8
|
his inventory was used to determine individuals' problem-solving skills.
The scale was developed by Heppner et al. and its Turkish adaptation was performed .
The scale is a six-point Likert-type instrument consisting of 35 items and includes the subdimensions of "impulsive approach," "avoidant approach," "thinking approach," "confident approach," "evaluative approach," and "problem-solving self-confidence approach."
Items 9, 11, 22, and 29 are not scored.
The total score ranges from 31 to 186, and lower scores indicate higher problem-solving ability.
|
Baseline and Week 8
|
|
Melbourne Decision Making Questionnaire:
Time Frame: Baseline and Week 8
|
This scale was used to assess self-esteem in decision making and decision-making styles.
It was developed by Mann, Burnett, Radford, and Ford , and its Turkish adaptation has been conducted.
The scale consists of two parts.
The first part measures self-esteem in decision making (self-confidence) and includes six items; items 1, 3, and 5 are positively scored, while items 2, 4, and 6 are reverse scored.
The maximum possible score is 12, and higher scores indicate higher self-esteem in decision making.
The second part consists of 22 items and assesses decision-making styles, including panic, avoidant, procrastinating, and vigilant styles.
|
Baseline and Week 8
|
|
Short Form Health Survey (SF-12):
Time Frame: Baseline and Week 8
|
This questionnaire was used to assess individuals' quality of life.
It measures perceived health status and functional health using 12 items.
The SF-12 consists of 12 items covering physical functioning (2 items), physical role (2 items), bodily pain (1 item), general health (1 item), vitality (1 item), social functioning (1 item), emotional role (2 items), and mental health (2 items).
Higher scores indicate better health status .
The Turkish adaptation of the scale was performed by Soylu and Kütük.
|
Baseline and Week 8
|
|
Body Awareness Questionnaire:
Time Frame: Baseline and Week 8
|
This questionnaire was used to evaluate changes in individuals' body awareness.
It aims to identify normal or abnormal bodily cues such as sensitivity to body cycles and rhythms, the ability to detect subtle changes in normal functioning, and the ability to anticipate bodily reactions.
The questionnaire consists of 18 items and includes four subdimensions: prediction of bodily responses, sleep-wake cycle, anticipation of illness onset, and awareness of changes in bodily processes and responses .
Higher scores indicate a higher level of body awareness.
The Turkish version of the scale was adapted by Karaca et al.
|
Baseline and Week 8
|
|
Lawton-Brody Instrumental Activities of Daily Living Scale
Time Frame: Baseline and Week 8
|
his scale was used to evaluate impairment in individuals' daily living activities.
The Turkish validity and reliability study was conducted by Işık et al. in 2020, and the internal consistency coefficient (Cronbach's alpha) for the overall scale was 0.843.
The scale consists of eight items assessing the ability to use the telephone, shop, prepare food, perform housework, do laundry, use transportation, and manage finances.
Each item is scored as 0 (unable or partially able) or 1 (able).
The total score ranges from 0 (low functioning, dependent) to 8 (high functioning, independent), with lower scores indicating greater dependence.
|
Baseline and Week 8
|
|
International Physical Activity Questionnaire - Short Form (IPAQ-SF):
Time Frame: Baseline and Week 8
|
This questionnaire was used to determine individuals' physical activity levels.
It was developed with the support of the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), and its Turkish validity and reliability study was conducted by Sağlam et al.
The form provides information regarding the time spent in light, moderate, and vigorous physical activities, as well as sitting time.
For each activity level, a fixed MET (metabolic equivalent) value is multiplied by the number of days and minutes to obtain a "MET-minutes/week" score.
The assigned MET values are 3.3 for walking, 4 for moderate-intensity activity, and 8 for vigorous-intensity activity.
Physical activity levels are classified as inactive (<600 MET-min/week), minimally active (600-3000 MET-min/week), and highly active (>3000 MET-min/week).
|
Baseline and Week 8
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Trabzon University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dysmenorrhea
-
University of PotsdamNot yet recruitingDysmenorrhea | Dysmenorrhea Primary | Dysmenorrhea Secondary | Dysmenorrhea Symptom
-
University of SharjahNot yet recruiting
-
Cairo UniversityRecruitingPrimary DysmenorrheaEgypt
-
Cairo UniversityCompletedPrimary DysmenorrheaEgypt
-
Ankara UniversityThe Scientific and Technological Research Council of TurkeyNot yet recruiting
-
Camilo Jose Cela UniversityNot yet recruiting
-
Cairo UniversityNot yet recruitingPrimary DysmenorrheaEgypt
-
Rana Salem Abdelghany AliCompletedPrimary DysmenorrheaEgypt
-
Cynthia del Rocío Márquez BeltránUniversity of HuelvaCompletedPrimary Dysmenorrhea | Menstrual Pain | Menstrual Distress \(Dysmenorrhea\)Spain
-
Dr. Mehak NaeemUniversity of Health Sciences LahoreRecruiting
Clinical Trials on Relaxation exercise group
-
TC Erciyes UniversityCompletedEffect of Progressive Relaxation ExerciseTurkey
-
Lithuanian Sports UniversityCompletedNeck Pain | Non-specific Neck PainLithuania
-
Ege UniversityRecruiting
-
Ataturk UniversityRecruitingAnxiety | Surgery | Fear | Relaxation Exercise | Therapeutic ClownTurkey (Türkiye)
-
Cumhuriyet UniversityCompletedRelaxation Exercises and Training After Cesarean SectionTurkey (Türkiye)
-
TC Erciyes UniversityCompletedEpilepsy in ChildrenTurkey
-
Istanbul Sabahattin Zaim UniversityCompleted
-
Hacettepe UniversityCompleted
-
Ataturk UniversityNot yet recruitingPalliative Care | Caregiver | Relaxation Therapy
-
Bandırma Onyedi Eylül UniversityCompletedLumbar Disc HerniationTurkey