Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04652999
Status:
COMPLETED
Last Update Posted:
2022-05-19
First Post:
2020-10-30
Brief Title:
Relaxation Intervention in Patients With Diabetic Foot Ulcer
Sponsor:
University of Minho
Organization:
University of Minho
Study Overview
Official Title:
Relaxation Intervention in Patients With Diabetic Foot Ulcer A Pilot Randomized Controlled Trial With a Nested Qualitative Study
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetic foot ulcers DFU are one of the most serious complications of diabetes and can lead to amputations in 85 of cases resulting in physical psychological family social and economic consequences Psychological interventions can contribute to the improvement of wound healing and relaxation in particular seems to contribute to faster wound healing More research is needed to assess the effectiveness of different types of intervention on different types of wounds in particular on chronic wounds such as DFU
This is a Pilot Randomised Controlled Study of a Psychological Intervention that aims to evaluate the feasibility and acceptability of a muscle relaxation intervention with guided imagery experimental group - EG compared to a neutral guided imagery placebo active control group - ACG and a group that does not receive any psychological intervention passive control group - PCG to inform a future definitive Randomised Controlled Study RCT that tests its effectiveness This study will also examine qualitatively the perspectives of patients with DFU on the relaxation intervention in order to check its acceptability and applicability as well as the perspectives of health professionals on this adjuvant therapy its applicability and integration into the care system of multidisciplinary diabetic foot consultations
Participants have a diagnosis of Diabetes Mellitus and Diabetic Foot one or two chronic ulcers active at the time of assessment and clinical levels of stress or anxiety or depression Participants will be randomized by the three conditions - EG ACG and PCG - and assessed on the day of the first consultation or nursing treatment for chronic DFU T0 two months later T1 and six months later T2 follow-up Two weeks after T1 an interview will be conducted with patients with DFU that benefited from the relaxation sessions and to the health professionals who provided them the DFU care
The results of the present study will contribute for a better understanding of DFU progression healing prevention of re-ulceration and future amputations and consequently for the improvement of patients quality of life
This is a Pilot Randomised Controlled Study of a Psychological Intervention that aims to evaluate the feasibility and acceptability of a muscle relaxation intervention with guided imagery experimental group - EG compared to a neutral guided imagery placebo active control group - ACG and a group that does not receive any psychological intervention passive control group - PCG to inform a future definitive Randomised Controlled Study RCT that tests its effectiveness This study will also examine qualitatively the perspectives of patients with DFU on the relaxation intervention in order to check its acceptability and applicability as well as the perspectives of health professionals on this adjuvant therapy its applicability and integration into the care system of multidisciplinary diabetic foot consultations
Participants have a diagnosis of Diabetes Mellitus and Diabetic Foot one or two chronic ulcers active at the time of assessment and clinical levels of stress or anxiety or depression Participants will be randomized by the three conditions - EG ACG and PCG - and assessed on the day of the first consultation or nursing treatment for chronic DFU T0 two months later T1 and six months later T2 follow-up Two weeks after T1 an interview will be conducted with patients with DFU that benefited from the relaxation sessions and to the health professionals who provided them the DFU care
The results of the present study will contribute for a better understanding of DFU progression healing prevention of re-ulceration and future amputations and consequently for the improvement of patients quality of life
Detailed Description:
General Aims
This pilot RCT aims to assess the feasibility and acceptability of a muscle relaxation intervention with guided imagery experimental group - GE compared to a neutral guided imagery placebo active control group - ACG and a group that does not receive any psychological intervention passive control group - PCG prior to the implementation of a future definitive RCT that will assess its effectiveness
This study will also examine qualitatively the perspectives of patients with DFU regarding the relaxation intervention in order to check its acceptability and applicability as well as the perspectives of health professionals on this adjuvant therapy its applicability and integration into the multidisciplinary team of diabetic foot consultations
Pilot RCT specific aims
1 To evaluate the rates of eligibility recruitment and adherence to the study protocol participation in follow-up and withdrawal The degree of patient satisfaction with the relaxation intervention will also be assessed
2 To verify the feasibility of the assessment protocol and to obtain preliminary estimates of the effects of the intervention on health outcome measures degree of DFU healing DFU-related quality of life anxiety depression and stress DFU representations and physical and mental quality of life
3 Synthesize the information to estimate the sample size required for a future definitive RCT
Qualitative study nested in Pilot RCT specific aims
4 To understand the perspective of patients and health professionals about the relaxation sessions
5 To explore the contribution of the relaxation sessions to the DFU healing and patients quality of life
6 To describe the changes perceived in the patient during the period of relaxation sessions
7 To analyse the relevance of implementing relaxation sessions in the multidisciplinary team consultation of diabetic foot
Data Analysis
To assess the feasibility of this pilot study aim 1 the rates of eligibility recruitment and adherence to the study protocol participation in the follow-up and withdrawal will be calculated and its results will be presented in percentage The results of the degree of satisfaction with the intervention will be presented through mean and standard deviation To obtain preliminary estimates of the intervention effects on health outcome measures aim 2 descriptive measures of the respective variables means and standard deviations will be calculated and Generalised Mixed Models will be used to check for statistically significant differences over time in the different groups Data will be analysed using IBM SPSS Statistics 26 for Mac Finally from the data obtained the sample size for a future definitive RCT will be calculated aim 3
To answer the aims 4 to 7 a semi-structured interview guide consisting of open-ended questions will be administered to patients with DFU that benefited from the relaxation sessions and to the health professionals who provided them the DFU care This script will remain unchanged throughout the interviews The audio recording of the interviews will be done using a tablet transcribed verbatim and anonymised in order to safeguard participants and data confidentiality The transcripts of the interviews will be analysed in the same order as conducted using the thematic content analysis technique Bardin 2016
Sample size calculation
The sample size calculation for a pilot RCT considering the average effect size of 05 a statistical power of 80 and a significance level of 5 revealed that 12 participants were needed in each of the groups Cocks Torgerson 2013 This approach considers that a one-sided 80 confidence interval for the effect size will exclude the minimum clinically significant difference if the null hypothesis is true Brown Lilford 2006
Procedure
The doctor or nurse in the medical appointment identifies patients that meet the medical inclusion criteria Patients are invited to participate in the study by the Researcher at the end of the medical appointment and are informed about the aims of the study and the voluntary nature of participation through informed and informative consent If patients agree to participate they will sign the consent form Nurses will then complete RESVECH 20 at the end of the appointment and doctors will complete the clinical questionnaire Afterwards the Researcher will accompany the patient to a room provided by the Hospital in order to administer the battery of questionnaires in the interview format
After answering the questionnaires the researcher will score the PSS and HADS instruments to identify the presence of significant clinical levels of stress anxiety and depression and if the patient is eligible at the end of that week the participant will be randomized into one of three possible groups
In the next diabetic foot appointment the respective participant will be informed about the group to which he or she has been allocated and whether will benefit if appropriate from four sessions of relaxation EG or neutral guided imagery ACG depending on the group If the participant is available the first session will take place on the same day The following sessions will be scheduled according to the medical diabetic foot consultations In each session two assessments of blood pressure and heart rate will be performed before starting the session and at the end of the session At the end of the fourth session the T1 assessment will be performed with a new administration of the questionnaires Six months after T0 the T2 follow-up evaluation will take place with the last administration of the questionnaires
The interviews with patients who completed the four sessions of relaxation and with health professionals will be conducted two weeks after T1 by a different researcher than the one involved in the intervention to reduce the bias of social desirability
This pilot RCT aims to assess the feasibility and acceptability of a muscle relaxation intervention with guided imagery experimental group - GE compared to a neutral guided imagery placebo active control group - ACG and a group that does not receive any psychological intervention passive control group - PCG prior to the implementation of a future definitive RCT that will assess its effectiveness
This study will also examine qualitatively the perspectives of patients with DFU regarding the relaxation intervention in order to check its acceptability and applicability as well as the perspectives of health professionals on this adjuvant therapy its applicability and integration into the multidisciplinary team of diabetic foot consultations
Pilot RCT specific aims
1 To evaluate the rates of eligibility recruitment and adherence to the study protocol participation in follow-up and withdrawal The degree of patient satisfaction with the relaxation intervention will also be assessed
2 To verify the feasibility of the assessment protocol and to obtain preliminary estimates of the effects of the intervention on health outcome measures degree of DFU healing DFU-related quality of life anxiety depression and stress DFU representations and physical and mental quality of life
3 Synthesize the information to estimate the sample size required for a future definitive RCT
Qualitative study nested in Pilot RCT specific aims
4 To understand the perspective of patients and health professionals about the relaxation sessions
5 To explore the contribution of the relaxation sessions to the DFU healing and patients quality of life
6 To describe the changes perceived in the patient during the period of relaxation sessions
7 To analyse the relevance of implementing relaxation sessions in the multidisciplinary team consultation of diabetic foot
Data Analysis
To assess the feasibility of this pilot study aim 1 the rates of eligibility recruitment and adherence to the study protocol participation in the follow-up and withdrawal will be calculated and its results will be presented in percentage The results of the degree of satisfaction with the intervention will be presented through mean and standard deviation To obtain preliminary estimates of the intervention effects on health outcome measures aim 2 descriptive measures of the respective variables means and standard deviations will be calculated and Generalised Mixed Models will be used to check for statistically significant differences over time in the different groups Data will be analysed using IBM SPSS Statistics 26 for Mac Finally from the data obtained the sample size for a future definitive RCT will be calculated aim 3
To answer the aims 4 to 7 a semi-structured interview guide consisting of open-ended questions will be administered to patients with DFU that benefited from the relaxation sessions and to the health professionals who provided them the DFU care This script will remain unchanged throughout the interviews The audio recording of the interviews will be done using a tablet transcribed verbatim and anonymised in order to safeguard participants and data confidentiality The transcripts of the interviews will be analysed in the same order as conducted using the thematic content analysis technique Bardin 2016
Sample size calculation
The sample size calculation for a pilot RCT considering the average effect size of 05 a statistical power of 80 and a significance level of 5 revealed that 12 participants were needed in each of the groups Cocks Torgerson 2013 This approach considers that a one-sided 80 confidence interval for the effect size will exclude the minimum clinically significant difference if the null hypothesis is true Brown Lilford 2006
Procedure
The doctor or nurse in the medical appointment identifies patients that meet the medical inclusion criteria Patients are invited to participate in the study by the Researcher at the end of the medical appointment and are informed about the aims of the study and the voluntary nature of participation through informed and informative consent If patients agree to participate they will sign the consent form Nurses will then complete RESVECH 20 at the end of the appointment and doctors will complete the clinical questionnaire Afterwards the Researcher will accompany the patient to a room provided by the Hospital in order to administer the battery of questionnaires in the interview format
After answering the questionnaires the researcher will score the PSS and HADS instruments to identify the presence of significant clinical levels of stress anxiety and depression and if the patient is eligible at the end of that week the participant will be randomized into one of three possible groups
In the next diabetic foot appointment the respective participant will be informed about the group to which he or she has been allocated and whether will benefit if appropriate from four sessions of relaxation EG or neutral guided imagery ACG depending on the group If the participant is available the first session will take place on the same day The following sessions will be scheduled according to the medical diabetic foot consultations In each session two assessments of blood pressure and heart rate will be performed before starting the session and at the end of the session At the end of the fourth session the T1 assessment will be performed with a new administration of the questionnaires Six months after T0 the T2 follow-up evaluation will take place with the last administration of the questionnaires
The interviews with patients who completed the four sessions of relaxation and with health professionals will be conducted two weeks after T1 by a different researcher than the one involved in the intervention to reduce the bias of social desirability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None