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How Does Basic Body Awareness Therapy Affect Pain Coping Strategies in Postmenopausal Women?

Primary Purpose

Low Back Pain, Neck Pain, Menopause

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Therapeutic Exercise Group
Therapeutic Exercise+Basic Body Awareness Therapy Group
Sponsored by
European University of Lefke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Postmenopausal women, Basic body awareness therapy, Pain coping

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Participants should have; 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. Exclusion Criteria: Presence of significant neurological disorders Presence of serious mental and psychological disorder

Sites / Locations

  • Cyprus Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Therapeutic Exercise Group

Therapeutic Exercise+Basic Body Awareness (BBAT) Group

Control Group

Arm Description

The therapeutic exercise protocol will be taught to patients in the first session and will be done 3 times a week for 12 weeks.

This 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.

This group will not receive any treatment.

Outcomes

Primary Outcome Measures

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.
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.
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).
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.
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).

Secondary Outcome Measures

Full Information

First Posted
May 30, 2023
Last Updated
July 16, 2023
Sponsor
European University of Lefke
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1. Study Identification

Unique Protocol Identification Number
NCT05893290
Brief Title
How Does Basic Body Awareness Therapy Affect Pain Coping Strategies in Postmenopausal Women?
Official Title
How Does Basic Body Awareness Therapy Effect Pain Coping Strategies in Postmenopausal Women? A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
November 16, 2023 (Anticipated)
Study Completion Date
May 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European University of Lefke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
The patients will be randomly assigned into three groups: Therapeutic Exercise (TE) Group, Therapeutic Exercise+Basic Body Awareness (TE+BBAT) Group, and Control Group. Each group will be treated for 12 weeks. Individuals will be evaluated in detail at the beginning and end of the study. The follow-up assessments of the study will be done 3 months after the conclusion of the treatments. Physical and sociodemographic characteristics will be evaluated by dedicated form. The body awareness of the participants will be evaluated Body Awareness Questionnaire (BAQ) developed by Shields, Mallory & Simon in 1989. The pain levels of the PmW will be measured with the Short Form McGill Pain Questionnaire. Pain coping strategies of PmW will be assessed with Pain Coping Inventory (PCI). The Oswestry Low Back Pain Disability Index will be used for evaluating the disability level caused by low back pain. The Neck Disability Index will be used for evaluating the disability level caused by neck pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Neck Pain, Menopause
Keywords
Postmenopausal women, Basic body awareness therapy, Pain coping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Exercise Group
Arm Type
Active Comparator
Arm Description
The therapeutic exercise protocol will be taught to patients in the first session and will be done 3 times a week for 12 weeks.
Arm Title
Therapeutic Exercise+Basic Body Awareness (BBAT) Group
Arm Type
Experimental
Arm Description
This 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will not receive any treatment.
Intervention Type
Other
Intervention Name(s)
Therapeutic Exercise Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Therapeutic Exercise+Basic Body Awareness Therapy Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Awareness Questionnaire (BAQ)
Description
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.
Time Frame
3 minutes
Title
McGill-Short Form Pain Questionnaire
Description
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.
Time Frame
5 minutes
Title
Pain Coping Strategies
Description
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).
Time Frame
5 minutes
Title
Oswestry Low Back Pain Disability Index
Description
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.
Time Frame
5 minutes
Title
Neck Disability Index
Description
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).
Time Frame
5 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants should have; 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. Exclusion Criteria: Presence of significant neurological disorders Presence of serious mental and psychological disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Havva Gozgen, PT, MSc
Phone
05338585171
Email
havvagozgen@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Beliz Belgen Kaygisiz, PT, PhD
Phone
05338648787
Email
bkaygisiz@eul.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beliz Belgen Kaygisiz, PT, PhD
Organizational Affiliation
European University of Lefke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cyprus Science University
City
Girne
State/Province
Trnc
ZIP/Postal Code
99320
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Havva Gözgen, MSc
Phone
5338585171
Ext
+90
Email
havvagozgen@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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How Does Basic Body Awareness Therapy Affect Pain Coping Strategies in Postmenopausal Women?

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