Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000763943
Ethics application status
Approved
Date submitted
9/06/2020
Date registered
27/07/2020
Date last updated
13/04/2021
Date data sharing statement initially provided
27/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the feasibility of osteopathy and psycho-education based therapy application in managing stress
Scientific title
Assessing the feasibility and influence of a combined osteopathy and psycho-education therapy on the levels of psychological and physiological stress in adult participants with moderate stress: A pilot study
Secondary ID [1] 301461 0
Nil known
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 317777 0
Mental health 317778 0
Condition category
Condition code
Mental Health 315845 315845 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief description of the Intervention (s) and steps in the therapy application:
The therapy package composed of two components; application of general osteopathic techniques and administration of stress management education.
After initial consultation and participants agreeing to proceed, participants were invited to the osteopathic teaching clinic (Unitec, Mount Albert campus), a general health screen was taken for each participant, which was adopted from the John Hopkins Medical School case history (John Hopkins Medicine, n.d.). This included gathering information regarding height, weight, heart rate and blood pressure. Following initial health screening and PSS-10 score (self-report of stress), eligible participants with acceptable health status and PSS-10 scores >14 were enrolled in the study. The therapy package was applied in two consecutive days, each session lasting up to 1 hour and 15 minutes. The steps for the two mutually agreed and scheduled consecutive sessions are detailed below.

Session one (1 to 1.25 hours)
1. Participants were given PIS and on arrival
2. Participants then completed the Consent Form
3. Rinsing of participant’s mouth with water five minutes before sample collection
4. Pre-intervention collection of saliva sample (Timepoint 1), for assessing biomarkers. Samples stored in collection chilly box for transportation and then stored in the -80°C freezer until processed.
5. Completion of self report stress questionnaires: modified Self report stress questionnaires (POMS and PSS-10).
6. Completion of adapted case history including blood pressure (BP) and heart rate (HR) measurement.
7. Application of the 10 selected general osteopathic techniques (GOT). Description of GOT is provided below after the two sessions description.
8. Delivery of scripted stress management education and handing out of associated pamphlet.
9. Completion of POMS and PSS-10 Questionnaire – post-treatment (Timepoint 2).
10. Collection of saliva samples – post-treatment (Timepoint 2). Participants were not asked to rinse their mouth post intervention.

At the end of the first session, the participants were asked routine health safety questions to ensure they were not or had not experienced any adverse effects of the treatment (e.g. questions regarding their current mood and/or whether they had any aches or pains). They were advised to contact the student researcher if they had any questions or experienced any effects from the treatment, such as feeling light-headed or headache. They were also advised to drink water throughout the day.

Session two (50-minutes to 1 hour)
Session two followed the same procedure and steps as session 1 (except first two steps). This session took place 24 hours after the initial session and included the following steps:
1. Rinsing of the participant’s mouth with water five minutes before sample collection
2. Collection of pre-intervention saliva samples (Timepoint 3)
3. Completion of pre-intervention stress questionnaires (POMS and PSS-10)
4. Application of the GOT and stress management education; the procedures were same as those administered during session one.
5. Completion of post-intervention self report stress questionnaires (POMS and PSS-10)
6. Collection of post-treatment saliva samples (Time point 4). Participants were not asked to rinse their mouth post intervention.

After the second session, participants were asked the 'routine health safety questions'. Participants with remaining high-stress levels (>19) were advised to consult their general health practitioner. All participants were given the chance to ask any final questions about the study, which included the collection of participant's feedback on every aspect of the therapy package (e.g. collection of saliva sample, GOT therapy, stress management package etc.). The session booking sheet was used to check the attendance (adherence) of participants to both sessions. They were also asked to leave their contact email to receive a summary of the study results.

Therapy delivered by: Two Master of Osteopathy research students who were professionally trained by clinicians and clinic tutors. These lead (student) researchers were experienced and competent in delivering these techniques in to patients in the Unitec's Osteopathy teaching Clinic. These students were supervised by two post-graduate research supervisors and an Osteopath (Clinic tutor).

Mode of administration - one-on one. Each participant was booked for the private sessions, no group activity or therapy application was undertaken.

Brief description of General osteopathic techniques:
Each participant was asked to lie supine on the treatment plinth they received the GOT routine applied to 10 different areas. These areas included the hip, sacroiliac joint, lumbar spine, thoracic spine and ribcage, glenohumeral joint, scapulothoracic joint, cervical spine, upper thoracic ribs, cervical spine and cranium region. The techniques included soft tissue massage, rhythmic joint articulation, myofascial release, gentle harmonics, muscle inhibition, and rib-raising. The student researcher individually tailored the application of each technique.
The length of time spent on performing each technique depended on the researcher's perception of tissue change. This included the feeling of the joint or area "relaxing" as the technique was applied to the area. This perception of tissue change was determined by the feeling of softness of the tissues, if they became more mobile and/or if they were more pliable to stretch. Then the student researcher moved on to the next area. Seven joint articulations and three soft tissue techniques were applied to the participant for a maximum of 30 minutes. Overall, the duration of each session varied between participants (range: 50 minutes to 1.25 hours; mean 60.7, SD 6.85). The sessions were flexible depending on the participant's perceived comfort level.

Stress management education and pamphlet:
The stress management and education pamphlet aimed to provide the participant with tools to help them identify stressors and manage their stress in everyday life. The stress management education used for this project included a scripted discussion about tools aimed to reduce tension and promote an overall sense of wellbeing. Stress management education was delivered after the GOT treatment. The participant was asked to slowly get up and off the treatment table at their own pace, and sit comfortably in a chair before receiving a 5-10 minute scripted session based on the Brief Cognitive-Behavioural Education Program (B-CBE) (Chiang et al., 2016) by the student researcher. The way the education script was delivered followed a pragmatic real-life setting, whereby the student researcher chose how to best deliver the information depending on the participant’s mood during the session. This led to the duration of delivery varying between 5-10 minutes.
Also, a pamphlet was given to the participant to take home and read in their own time. This contained information such as a basic and clear definition of stress, ways to identify stressors and some strategies to cope with, manage and overcome stress. These included sleep, exercise, visualisation, deep breathing, socialising, keeping a journal and creating a schedule. Participants were advised to try some of these strategies in their daily life.

Location of therapy administration: Unitec Osteopathy clinic, Carrington Rd,Unitec Gate 4, Building 61, Mount Albert, Auckland 1025
Intervention code [1] 317771 0
Treatment: Other
Intervention code [2] 317773 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324052 0
Self report measures of stress assessed by using two questionnaires;
perceived stress scale-10 (PSS-10)
Modified 24 items Profile of Mood Scale (POMS)
Timepoint [1] 324052 0
Session 1 (first day of intervention)
Timepoint 1: pre-intervention scores
Timepoint 2: post intervention (immediately after therapy application)

Session 2 (next day)
Timepoint 3: pre-intervention
Timepoint 4: post intervention (immediately after therapy application)
Primary outcome [2] 324053 0
Physiological stress biomarker: Cortisol levels in saliva samples
Timepoint [2] 324053 0
Saliva samples collected at following timepoints:

Session 1 (first day of intervention)
Timepoint 1: pre-intervention scores
Timepoint 2: post intervention (immediately after therapy application)

Session 2 (next day)
Timepoint 3: pre-intervention
Timepoint 4: post intervention (immediately after therapy application)
Primary outcome [3] 324267 0
Physiological stress biomarker: IL-6 levels in saliva samples.
Timepoint [3] 324267 0
Saliva samples collected at following timepoints:

Session 1 (first day of intervention)
Timepoint 1: pre-intervention scores
Timepoint 2: post intervention (immediately after therapy application)
Secondary outcome [1] 383631 0
Feedback collected from participants.
(to assess the feasibility of the therapy application).

Mode: informal (non structured interview) where study specific questions were asked.
Questions were related to all aspects of therapy application.
Participants were also provided with an opportunity to add any comment/s.
Timepoint [1] 383631 0
Session 2 (next day)
post intervention
Method of measurement: study related questions (on all aspects of therapy application).
Secondary outcome [2] 383632 0
Challenges encountered by the researchers.
(to assess the feasibility of the therapy application).

Method of measurement: Informal (non-structured interview type), study specific questions (on all aspects of therapy application) were asked, including sessions' timing, recruitment, therapy application and sample collection).
Timepoint [2] 383632 0
During enrollment,
During administration of questionnaires,
Saliva sample collection, transport and storage.
Post therapy application.
Secondary outcome [3] 384219 0
This is a primary outcome:
Physiological stress Biomarker: sIgA levels in saliva samples.
Timepoint [3] 384219 0
Primary outcome timepoints:

Saliva samples collected at following timepoints:

Session 1 (first day of intervention)
Timepoint 1: pre-intervention scores
Timepoint 2: post intervention (immediately after therapy application)
Secondary outcome [4] 384221 0
Assessment of any adverse events (Example: Light- headedness, fatigue and muscular pain).

Method of measurement:
By asking health related questions to participants.
By observing any making a note of any adverse events.
By encouraging participants to inform researchers about any concern or adverse effects.
Timepoint [4] 384221 0
During the therapy application and post therapy application.

Eligibility
Key inclusion criteria
• Participants (women and men) over the age of 18
• The ability to communicate in English
• The ability to provide informed consent
• The presence of moderate stress levels (>14 on the PSS-10) at the time of screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Presence of any pathological conditions including diabetes, Addison’s disease, hypopituitarism, Cushing’s syndrome, heart conditions, arthritis, any known chronic inflammatory condition and/or cancer)
• Breathing difficulties
• Hypertension (controlled by medication)
• Current musculoskeletal condition or injury
• Neurological symptoms (numbness, tingling, nausea, vomiting, sense of weakness)
• Presence of any oral disease
• Current steroidal use (not including hormone replacement therapy for women participants)
• Report of substance or alcohol abuse
• Pregnant or recently post-partum (for women participants).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable.
The study was uncontrolled pilot trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant numbers:
The two student practitioners leading the enrollment of participants aimed to enroll 20 participants (10 women and 10 men), in total 18 participants were enrolled (11 women and 07 men). Sample size calculations were not carried out and were not considered mandatory due to the study being a pilot study assessing the feasibility of the therapy application in a small sample size, in an osteopathic clinical setting.

Data transcription and analyses carried out in the study:
All paper-based responses from participants were scanned to create an electronic copy stored on password-protected devices. Electronic copies were kept as a back-up. The lead (student) researchers entered the data received from the PSS-10 and POMS results into a Microsoft spreadsheet in Excel, at the end of each session. Total scores for each questionnaire were calculated (as per published literature). All demographic data and general feedback from the participants concerning the feasibility of the entire approach were recorded into the Excel spreadsheet. Adverse events (if any) experienced by participants or observed by the researcher were recorded. The data from the assessed biomarkers were processed by a Research Fellow at the Spinal Cord Research Injury Unit laboratories, Grafton Campus, Auckland University. The final adjusted values of all biomarkers were provided in an excel spreadsheet. The lead (student) researchers then ran t-tests (paired two-tailed t-test) and normality tests on PSS-10, POMS and the biomarkers data.

Psychological stress analysis:
Once completed, all self-report score of stress (PSS-10 and POMS questionnaires) were collected from the participants. Copies were stored in each individual's file until the end of the intervention. After this, the responses were scanned, and electronic copies were made and saved in password protected folders. Only the student (lead) researchers and their supervisors had access to this. Responses from participants from the PSS-10 and POMS were entered into Microsoft Excel. Scores of subscales from each questionnaire were calculated within Excel and results were summed to determine totals for each questionnaire at each timepoint. Total scores were then imported from Microsoft Excel into SPSS for data screening for normality and descriptive statistics from both psychological parameters taken at session one (Timepoints 1 and 2) and session two (Timepoints 3 and 4). Inferential analyses were also carried out in SPSS. Specifically, paired-sample T-tests (or the non-parametric equivalent Shapiro-Wilk) were completed between Timepoints for both psychological questionnaires.

Physiological analysis:
The biomarker results were provided by a Research Fellow from the Spinal Cord Research Injury Unit laboratories, Grafton Campus, Auckland University. To determine the change between baseline and various timepoints, salivary levels of cortisol, IL-6 and sIgA were tabulated from both sessions, imported to SPSS from Mircosof Excel, and compared using paired t-tests using SPSS software. Graphs were created using Microsoft Excel to assess observable differences and changes between the selected timepoints in each individuals and over-all changes among all participants. Where possible assessments were also done to see the patterns of change in men and women separately.

Assessment of correlation between studied parameters:
Since this being a feasibility, pilot study with small sample number. Statistical analyses to assess correlations (Pearson’s or Spearman’s correlation) could not be conducted. The lead (student) researchers looked across all the parameters for any observational relationship between PSS-10/POMS and biomarkers, by assessing all graphs for any similarities in the pattern/changes seen over the course of the intervention. Finally, the student researcher looked at individual-level data for potential relationships between physiological and perceived stress markers at the individual level.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/03/2019
Date of last participant enrolment
Anticipated
Actual
4/07/2019
Date of last data collection
Anticipated
Actual
5/07/2019
Sample size
Target
20
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 22660 0
New Zealand
State/province [1] 22660 0
Auckland

Funding & Sponsors
Funding source category [1] 305895 0
University
Name [1] 305895 0
Unitec Institute of Technology
Country [1] 305895 0
New Zealand
Funding source category [2] 306069 0
University
Name [2] 306069 0
The University of Auckland
Country [2] 306069 0
New Zealand
Primary sponsor type
University
Name
The Unitec Institute of Technology
Address
Osteopathy Department
139 Carrington Road, Mount Albert, Auckland 1025
Country
New Zealand
Secondary sponsor category [1] 306528 0
None
Name [1] 306528 0
none
Address [1] 306528 0
None
Country [1] 306528 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306153 0
Unitec Research Ethics Committee
Ethics committee address [1] 306153 0
Ethics committee country [1] 306153 0
New Zealand
Date submitted for ethics approval [1] 306153 0
07/11/2018
Approval date [1] 306153 0
27/11/2018
Ethics approval number [1] 306153 0
2018-1066

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102894 0
Dr Shamim Shaikh
Address 102894 0
Department of Osteopathy, Building 60, Office 1016
School of Community Studies
Unitec Institute of Technology
139 Carrington Road, Mount Albert
Auckland 1025
Country 102894 0
New Zealand
Phone 102894 0
+6498928286
Fax 102894 0
Email 102894 0
[email protected].
Contact person for public queries
Name 102895 0
Shamim Shaikh
Address 102895 0
Department of Osteopathy, Building 60, Office 1016
School of Community Studies
Unitec Institute of Technology
139 Carrington Road, Mount Albert
Auckland 1025
Country 102895 0
New Zealand
Phone 102895 0
+6498928286
Fax 102895 0
Email 102895 0
[email protected].
Contact person for scientific queries
Name 102896 0
Shamim Shaikh
Address 102896 0
Department of Osteopathy, Building 60, Office 1016
School of Community Studies
Unitec Institute of Technology
139 Carrington Road, Mount Albert
Auckland 1025
Country 102896 0
New Zealand
Phone 102896 0
+6498928286
Fax 102896 0
Email 102896 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.