How Does Basic Body Awareness Therapy Effect Pain Coping Strategies in Postmenopausal Women?
1 other identifier
interventional
54
1 country
1
Brief Summary
Exercise interventions are deemed essential for the effective management of patients with pain. Various therapy methods have been shown in the literature for pain and coping with pain. However, there is no study investigating the effectiveness of Basic Body Awareness Therapy in pain and coping with pain. In this respect, our study will contribute to the literature. The aim of our study is to compare the effectiveness of Basic Body Awareness Therapy and Therapeutic Exercises on pain coping strategies of Postmenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable low-back-pain
Started May 2023
Typical duration for not_applicable low-back-pain
1 active site
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
First Submitted
Initial submission to the registry
May 30, 2023
CompletedStudy Start
First participant enrolled
May 31, 2023
CompletedFirst Posted
Study publicly available on registry
June 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedOctober 4, 2024
July 1, 2023
1.2 years
May 30, 2023
October 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Body Awareness Questionnaire (BAQ)
Body awareness of the participants will be evaluated Body Awareness Questionnaire (BAQ) developed by Shields, Mallory \& Simon. BAQ is a questionnaire that aims to determine the normal or abnormal sensitivity level of body composition. It consists of four subgroups (Attention to changes in body process and responses, sleep-wake cycle, prediction at onset of illness, prediction of body responses) and a total of 18 statements. The participant will be asked to rate each statement with numbers from one to seven (1 = not at all true for me, 7 = completely true for me). Rating in the survey is done as a total score. It is concluded that the higher the total score to be obtained from the questionnaire, the better the body awareness.
3 minutes
McGill-Short Form Pain Questionnaire
The pain levels of the PmW will be measured with the Short Form McGill Pain Questionnaire. The questionnaire, developed by Melzack in 1987 and the validity and reliability of the Turkish version of which was demonstrated in 2007, is widely used in measuring pain. This questionnaire consists of a total of 15 descriptive words to determine the sensory (11 words) and affective (4 words) dimensions of pain. In this section, the severity of pain (0=absent, 1=mild, 2=moderate, 3=severe) is evaluated. In addition, the pain felt at the time of measurement is measured with the Visual Analogue Scale (VAS) and the total pain intensity is measured with a 10-point Likert scale. On this scale, 1 = no pain, 10 = unbearable pain.
5 minutes
Pain Coping Strategies
Pain coping strategies of PmW will be assessed with Pain Coping Inventory (PCI). The scale developed by Kraaimaat and Evers evaluates how often chronic pain patients use behavioral and cognitive methods to cope with pain. The original form of the scale includes six dimensions as pain transformation, distraction, reducing demands, retreating, worrying, and resting. Pain transformation, comforting thinking, and distraction are active coping methods; retreat, worrying, and resting are passive coping methods. The scoring options range from 1 (almost none) to 4 (very often).
5 minutes
Oswestry Low Back Pain Disability Index
The Oswestry low back pain disability index (OLBPDI), first published in 1980, was developed to assess pain-related disability in people with acute, subacute, or chronic low back pain. It includes 1 item related to pain and 9 items related to activities of daily living (personal care, lifting, walking, sitting, standing, sleeping, social life and travel). Each item is measured on a 6-point ranking scale from best to worst-case scenario. A total score of 0-4 indicates no disability, 5-14 indicates mild disability, 15-24 indicates moderate disability, 25-34 indicates severe functional disability, and 35-50 indicates full functional disability.
5 minutes
Neck Disability Index
The questionnaire, which evaluates subjective symptoms and activities of daily living, consists of 10 sections (pain severity, lifting weights, sleep, reading, driving, headache, concentration, work life, personal care, and leisure activities). For each section, there are 6 items ranging from 0-5 points. The total score ranges from 0 to 50 (0: no excuse; 50: maximum excuse). The total score obtained from the questionnaire expresses the severity of neck disability (0-4 points no disability, 5-14 points mild disability, 15-24 points moderate disability, 25-34 points severe disability, and over 35 points total disability).
5 minutes
Study Arms (3)
Therapeutic Exercise Group
ACTIVE COMPARATORThe therapeutic exercise protocol will be taught to patients in the first session and will be done 3 times a week for 12 weeks.
Therapeutic Exercise+Basic Body Awareness (BBAT) Group
EXPERIMENTALThis group will receive BBAT as well as therapeutic exercises for 3 times a week for 12 week. Therapeutic exercises will include strengthening, stretching, and stabilization exercises. BBAT will include postural alignment, breathing, and cognitive exercises.
Control Group
NO INTERVENTIONThis group will not receive any treatment.
Interventions
Therapeutic exercise sessions will begin with a short educational talk that provides information on proper body mechanics, and the benefits of exercise, followed by simple warm-ups and three different stretching and five different strengthening exercises that emphasize hip, abdominal, and back muscles. The frequency of repetitions of each stretching and strength exercise will be 10 with a holding time of 10 sec. Each set of strengthening exercises will be followed by a different set of stretching exercises. Sessions will end with a short unguided period of deep slow breathing.
This group will receive BBAT as well as therapeutic exercises. Therapeutic exercises will include strengthening, stretching, and stabilization exercises. BBAT will include postural alignment, breathing, and cognitive exercises.
Eligibility Criteria
You may qualify if:
- Chronic lower back or neck pain lasting at least six months
- Gone through the menopausal transition naturally within the last year
- Not received a physiotherapy approach for pain management in the last six months
- Be able to read and write in Turkish.
You may not qualify if:
- Presence of significant neurological disorders
- Presence of serious mental and psychological disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cyprus Science University
Girne, TRNC, 99320, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beliz Belgen Kaygisiz, PT, PhD
European University of Lefke
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2023
First Posted
June 7, 2023
Study Start
May 31, 2023
Primary Completion
July 31, 2024
Study Completion
July 31, 2024
Last Updated
October 4, 2024
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share