The Impact of Dynamic Neuromuscular Stabilization on Pregnancy

NCT06239753 | Recruiting

• 1 other identifier: KLKŞH
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized controlled study is to determine the pregnancy and childbirth outcomes of using the DNS method to facilitate anatomical and physiological adaptations during pregnancy.

Conditions

Pregnant; Exercise

Keywords

Pregnancy; Stabilization; Exercise

Outcome Measures

Primary Outcomes (7)

• Pelvic Floor Muscle Measurements

  Pelvic floor muscle measurements will be assessed by a specialist in obstetrics and gynecology using transperineal ultrasonography. The Voluson 730 Pro ultrasound device will be used for assessment. A standard bladder filling protocol will be implemented before measurements. For this, women will be instructed to drink 600-750 ml of water one hour before the evaluation and refrain from emptying their bladders until the end of the test. Women will be positioned on their backs with knees flexed at 60°, and a pillow will be placed under their head. The ultrasound transducer will be placed suprapubically in the caudo-posterior direction to visualize the posterior inferior aspect of the bladder in the transverse plane during the first rest period. A first marker will be placed at the base of the bladder during this resting period. Women will be asked to contract their pelvic floor muscles during the assessment. The ultrasound image will be frozen during this contraction, and a second marker

  Between the 11th and 36th weeks of pregnancy,

• The Pittsburgh Sleep Quality Index

  Assessing sleep quality over the past month, the PSQI consists of a total of 24 questions. The total score ranges from 0 to 21. A total score higher than 5 indicates poor sleep quality. The scale will be applied twice, for the first and last application.

  Between the 11th and 36th weeks of pregnancy,

• State-Trait Anxiety Inventory

  Aims to measure individuals' levels of state and trait anxiety. The scale consists of two subscales, each comprising 20 items. An increase in scores from the scale indicates a higher level of anxiety. The scale will be applied twice, for the first and last application. The total score obtained from the scale varies between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. The average score level determined in the applications varies between 36 and 41.

  Between the 11th and 36th weeks of pregnancy,

• Oswestry Skalası

  The questionnaire related to lower back pain consisting of a total of 10 questions, each with 6 options. The scale assigns a minimum score of 0 and a maximum score of 5 to each question. The overall possible score ranges from 0 to 50. An increase in the total score collected from the questionnaire indicates a worsening of the pain condition. The scale will be applied twice, for the first and last application.

  Between the 11th and 36th weeks of pregnancy,

• Multidimensional Scale of Perceived Social Support

  The questionnaire based on the subjective evaluation of social support received from family, friends, and significant others in individuals' social environments. The questionnaire examines three dimensions: family, friends, and significant others, totaling 48 questions with four questions evaluating each dimension. Each item in the scale is rated on a 7-point Likert scale ranging from strongly disagree to strongly agree. Scores obtained from the three separate dimensions are summed to calculate subscale scores, and the total scale score is obtained by summing the scores from all subscales. Higher scores from both the scale and its subscales indicate a higher perceived level of social support. The scale will be applied twice, for the first and last application. The score that can be obtained from the scale varies between 7 and 84.

  Between the 11th and 36th weeks of pregnancy,

• The Fatigue Severity Scale

  The Fatigue Severity Scale (FSS) was developed by Krupp et al. in 1989. The scale consists of a total of 9 items, and each item is rated on a scale of 1-7 (1=strongly disagree, 7=strongly agree). The total score is obtained by dividing the sum of scores by the number of scale items. The possible total score ranges from 9 to 63, and when divided by the number of items, the lowest possible score is 1, while the highest is 7. A higher score indicates an increased level of fatigue. The scale will be applied twice, for the first and last application.

  Between the 11th and 36th weeks of pregnancy,

• Pregnancy Weight Gain

  The weight of the pregnant woman will be measured at her first application and at her last application using the scale currently used for pregnant women.

  Between the 11th and 36th weeks of pregnancy,

Secondary Outcomes (2)

• Blood pressure arterial (mmHg)

  Between the 11th and 36th weeks of pregnancy,

• pulse rate measurements

  Between the 11th and 36th weeks of pregnancy,

Study Arms (3)

Dynamic Neuromuscular Stabilization Applied

EXPERIMENTAL

Intervention Group I will receive DNS (Dynamic Neuromuscular Stabilization) applications in the hospital, led by a physiotherapist, once a week for 10 weeks. During each session, participants will be instructed to perform the DNS exercises at home and take notes. They will receive reminders via short message service (SMS) to practice the exercises at home. The DNS application for pregnant women involves checking the breathing pattern before starting exercises in all sessions. Pregnant women will be instructed to breathe through the nose, and if they find it challenging to maintain nasal breathing, the Body Oxygen Level Test (BOLT) score will be measured. If the BOLT score is low, guidance will be provided on how to increase it by adjusting the breathing technique."

Behavioral: Dynamic Neuromuscular Stabilization

Standard Prenatal Education Program Implementation

EXPERIMENTAL

The group will receive the standard prenatal education program, consisting of 5 sessions of general education and 2 sessions of standard pregnancy exercises and respiratory exercises, as part of the hospital's prenatal education program. The educational topics will include one-hour sessions on pregnancy and nutrition, postpartum care and family planning, baby care and infant massage, breastfeeding and lactation education, and first aid for infants, under the headings of childbirth and coping methods for labor pain

Behavioral: Standard Prenatal Education Program Implementation

Control

NO INTERVENTION

The control group will consist of pregnant women attending routine examinations at the hospital's maternity clinic. As per hospital policy, routine breastfeeding education is provided after the 32nd week during regular prenatal check-ups at the hospital.

Interventions

Dynamic Neuromuscular Stabilization BEHAVIORAL

Conducting routine pregnancy examinations. Measurement of pelvic floor muscle dimensions. Providing education through prenatal classes. Application of Dynamic Neuromuscular Stabilization (DNS).

Dynamic Neuromuscular Stabilization Applied

Standard Prenatal Education Program Implementation BEHAVIORAL

Conducting routine pregnancy examinations. Measurement of pelvic floor muscle dimensions. Providing education through prenatal classes.

Standard Prenatal Education Program Implementation

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primiparity
• Singleton Pregnancy
• Gestational Age Between 11-13 Weeks
• Age Between 20-35 Years
• Body Mass Index in the Range of 18-30
• Receiving Pregnancy Check-ups at the Hospital where the Research is Conducted

You may not qualify if:

• Presence of a heart condition affecting hemodynamics
• History of restrictive lung disease
• Multiple pregnancies
• Severe anemia
• Movement-restricting musculoskeletal system anomalies

Sponsors & Collaborators

• Dondu Kurnaz: lead

Study Sites (1)

Lütfi Kırdar Şehir Hastanesi

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Elif Ünlügedik Sayın, Dr.

  KLKŞH

  PRINCIPAL INVESTIGATOR

• Sunahan Koyuncu, Ftrp

  KLKŞH

  STUDY CHAIR

• Döndü Kurnaz

  KLKŞH

  STUDY DIRECTOR

• Deniz Akyıldız

  Sütçü İmam Unıversity

  STUDY CHAIR

Central Study Contacts

Döndü Kurnaz, Dr

CONTACT

5052381105; zsk2001@hotmail.com

Deniz Akyıldız, Doç. Dr.

CONTACT

denizbtm@gail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The complete randomization technique will be used for participant allocation to groups. This will be conducted through the https://www.randomizer.org/ website. Three computer-generated randomization sequences will be applied on a one-to-one basis. It has been observed that some numbers are assigned to all three groups in this system. To manage this situation, for individuals matching the same number, the person corresponding to that number in the group where the number first appeared will be assigned, and the next person will be assigned to the next group with the first unassigned number. Opaque envelope method will be used for group allocation. The researcher conducting the intervention and collecting the data forms will not be blinded to the groups, but the researchers responsible for measuring pelvic floor muscles, conducting analyses, and writing the findings will be blinded to the groups
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor Associate Professor

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: February 2, 2024
• Study Start: July 23, 2024
• Primary Completion: January 2, 2025
• Study Completion: July 2, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)