A Study on the Development of Cranial Traction therapy Program for Facial Non-symmertric Correction -Utilize Delphi technique

: The purpose of this study is to develop a cranial traction therapy program to help correct facial asymmetry of the hard tissues through the means of the treatment of soft tissues—a non-surgical therapeutic method for the correcting of facial asymmetry. We have formed a group of experts who have agreed to the study. In the primary survey, open questions were used. In the second survey, the results of the first survey were summarized and the degree of agreement was presented to the questions in each category. In the third survey, we conducted a statistical analysis of the degree of agreement on each item of question. All surveys also performed email. The distribution was calculated using the SPSS (ver.23.0) program, and the mean difference between the result and X² was calculated. The significance level was set to p<.05. Most of the questions attained a certain level of consensus by the experts (average of 4.0 or higher), it can be said that most are important and suitable questions. the results regarding the degree of importance for each of the points of evaluation made by the groups of experts in both the second and third stage of the cranial traction therapy program were verified using content validity ratio (CVR 77). The ratio for the cranial traction 13 points of evaluation was within the range of 0.40 ∼ 1.00, so the Delphi program for the cranial traction therapy verified that the content was valid. the temporal bone was performed in this study (item #11); the sphenozygomatic technique involving the zygomatic bone part and the part where traction of the sphenoid bone and the zygomatic bone was performed in this study (item #12); the temporozygomatic bone technique involving the zygomatic bone part and the part where traction of the zygomatic bone and the temporal bone was performed in this study (item #13); the zygomatic bone alternative technique involving the zygomatic bone part and the part where traction of the zygomatic bone and the maxilla was performed in this study (item #14). The treatment program developed by this study will thus prove effective.

asymmetry between the hard and soft tissues play when it comes to recognizing Class III asymmetry of the craniofacial skeleton [17].
The cranial grows up to over 90% of the adult size by the age of 5-7,;and the facial bones grow in an anterior-posterior direction before the age of 3 and in a posterior direction after the age of 3. At the age of 8, it changes from horizontal to vertical growth. Hereafter, as one ages, it grows in various types and directions,depending on the time and area,with different proportions of the facial and cranial parts in the head [21,22].
A normal growth results inthe ratio between the face and the cranium being even, achieving a harmonious appearance even if the left and the right may not be identical. However, in some severe cases, the harmony and balance of the face and the cranium canbe broken with a malfunction resultingfrom a defect in the normal process or an abnormal development during formation and growth [23].
Cranial traction treatment is a therapeutic method in which the suture surfaces that touch each other are pushed or pulled, keeping in mindthe fact that the craniofacial skeleton has its own movements. It increases each of the movements of the craniofacial skeleton and changes the frame of the otherwise limited cranial and facial bones [24]. It is therapy that applies adequate time and intensity to effect changes in the skeleton by the direction of the unique movements of the cranial and facial bones to treat facial asymmetry, according to the principle of craniosacral therapy in John E. Upledger's Craniosacral Therapy [25].
In particular, since the movements of the cranium bones affect the facial bones, suturing the cranial plays an important anatomical role in correcting facial asymmetry [26]. In Kim Kyung Suk's "Cranial Base Shape According to Skeletal Maloccusion and Effect of Ceania Base on Maxilla and Mandible" [27], it was stated that as the angle of base of the cranial increases, the condylion's position shifts toward the posterior upper part. By looking atthe resulting movement of the mandible rotating posteriorly and upward, one can predict that the change in the cranium bones forming the base of the cranial will be revealed to have beenrelated to facial asymmetry.
Park So Jeong's "Study on Patients with Facial Asymmetry According to the Skeletal Pattern" [28] presented that facial asymmetry is indicated by differences in the vertical length of the left and right structures or in the horizontal width of the midline. However, the result of classifying by skeletal shape type revealed that the differences in types have some level of significance. She saw that theskeletal shape could appear differently depending on the motion limitation of the cranial or facial bones, so in her study, shetried to examine whether the skeletal shape would measure differently after improving the limitations in themovements of each bone.
In addition, Lee Dae Jeong's "Comparison of Asymmetric Degree Between Maxillofacial Hard and Soft Tissue in Facial Asymmetric Subjects" [17] suggested that a difference in the degree of asymmetry between soft and hard tissues was seen in patients with facial asymmetry, indicating that an analysis of asymmetry using the soft tissues measurement items would be necessary along with that of the hard tissues for evaluation of facial asymmetry.
"The Effects of Golgeun Therapy on Facial Size Changes for Men in Their 20s and 30s" [31], We Soo Young's "The Effect of Golgeun Therapy on Facial Volume, Thickness of Cheekbone and Mastication Area" [3], Byeon In Hee's "Effect of Kyunggol Massage on Facial Reduction" [32]. However, there has never been a study evaluating facial asymmetry through either the soft or the hard tissues [33].
Therefore, it is fit that an effective facial correction method be designed to reduce the burden of side effects, as well as to save time and the cost for cosmetic surgery and treatment through a relatively simple procedure. This paper proposes for a scientific and systematic program to be developed using point-by-point stimulation manual therapy on the cranial bone suture surface-a method which is currently being used in orthopedics, oriental clinics, and therapy shops.
The purpose of this study is to develop a cranial traction therapy program to help correct facial asymmetry of thehard tissues through the means of the treatment of soft tissues-a non-surgical therapeutic method for the correcting of facial asymmetry..

Ethical approval
The study was approved by the ethtics committee of the CHA University (1044308-201911-HR-082-03/ 20200414). The applied protocols align with the Declaration of Helsinki. All participants signs an informed consent form.

Subject of Study
The purpose of this study is to develop a cranial traction therapy program for correcting facial asymmetry by conducting a study that takes into account the opinions.of various experts. Accordingly, the suitable method of choice was the Delphi technique, so that content validity for the development of the cranial traction therapy program can be verified.
When it comes to the Delphi technique, the selection of subjects is very critical to the success of the study. The panel of experts chosen was as follows; rehabilitation medical specialists (2), oriental medicine doctors (2), dentistry specialists (2), educators in the field of skin care that was in accordance with the higher education act (4), and master's or doctoral degree holders in skin care and cosmetology with more than 10 years of experience in the field (5). These experts were selected based on whether they had made previous presentations on the topic of cranial traction therapy or for their career experiences in their respective positions as researchers in their institutes. Table 1. Expert Panel Composition

Group
The First The Second The Third The panel of experts(Rehabilitation medical specialists, oriental medicine doctors , dentistry specialists) 6 6 6 master's or doctoral degree holders in skin care and cosmetology with more than 10 years of experience in the 5

Delphi survey tools
The Delphi technique is a method that allows for systematically inducing and contrasting perceived judgments on a specific subject [36]. What comes first in the process is the selection of experts in the relevant field. In order to increase the validity and credibility of the Delphi results, the following characteristics of the experts must be considered: their representativeness, relevance, expertise, integrity of participation, and adequacy in number [34,35]. Based on this theory, 15 experts were selected to take part inthe Delphi survey.
The number of experts to be selected for the panel can vary to meet the needs and size of the study, but a sample group of at least 10 people must formed in order for errorsin the mean values to be minimized and for the study to be credible.In general, samples numbering between 10 and 15 are accepted as valid in the Delphi survey [34,37]. The Delphi technique analyzes and synthesizes the responses given by the group of experts systematically to predict, diagnose, and solve certain problems until the goal of group consensus is achieved.

Selection of development tools
The 14 items for cranial traction therapy, which was based on the concept of manual therapy dealing with cranial structures, were selected by William Sutherland, who was a student of Still, the founder of osteopathic medicine on the human brain in 1943. The principle of biomechanics of all the joints in the human body is a passive and active system of the joints that distributes forces to achieve the balance between movement and restriction, and is system of balance that controls the action of movements. The selection based on the active system included joints outside of those that bring about movements.  Lambdoid suture gets depressed and the lambdoid suture surface of the posterior head boundary moves backward. Squamous suture surface gets depressed and the outer part of the parietal bone moves forward and gets ectropion [39].
Second, the movement of the facial bone transfers movement to all the bones that make up the maxillar bone and joints by delivering movement of sphenoid bone, temporal bone,and frontal bone to the maxillar bone [40].
The movement of the maxilla is the inner and outer rotational motion of the maxillar bone, where the upper part passes through the front of the maxillar bone,and the lower part moves at the slanted axis passing through the anterior lateral angle. While sphenoid bone is bent, the maxillar bone moves posteriorly as the suture between the maxillar bones is lowered and each maxillar bone moves backwards. The posterior boundary of the frontal bone is raised and the anterior surface moves anterior-laterally.
The movement of the zygomatic bone forms the joints with the maxillar bone, frontal bone and temporal bone, and rotates anterior-outward during bending, pulls the orbital boundary of the zygomatic bone towards the outside, letting the orbit widen, and the frontal bone protrusion moves to the anterior and lateral surfaces, and the temporal process of the zygomatic bone moves downward-outward [39].

In addition, through what was stated by Ferrario et al. in "Craniofacila Morphometry by Photographic
Evaluation" [19] and Haraguchi et al. in "Facial Asymmetry in Subjects with Skeletal Class III Deformity" [20] the 14 items of cranial traction therapy were set as shown at Table 3, and the measurement on the surgical procedures and facial correction displacement for 14 items in of cranial bone synaptic parts was performed, based on the evidence verifying that there is a difference in the degree of asymmetry between hard and soft tissues in the recognition of severe Class III craniofacial skeleton asymmetry.

Research procedure
In the first stage, evaluation papers about cranial traction therapy were given, and an example of said therapy was presented, so as to hint towards the correct answers for this test. In this study, the items for traction therapy which was conducted in the order as according to the designated numbers of each cranial suture were classified as according to Table 4, and the number of the treatment points for the traction therapy were from 1 to 3, and the processes of change of the parts were converted into data, keeping that of each of the treatment points separate.

processing data and Statistical analysis
There were a total of three surveys in this study. Prior telephone or face-to-face contact was made in order to present the study's purpose. The experts who agreed with the study were selected here. In the first survey, open-ended questions were used. For the second survey, the results of the first survey were organized and the degree of consensus for questions of each category were presented. This survey was done through email. For the third survey, a statistical analysis of the degree of consensus for the questions of each category was conducted. This survey was also done through email. The SPSS WIN 23.0 program will be used to apply the Delphi technique on the results of the second and third surveys, so that the following statistics can be calculated. Based on the consolidation of the responses from experts, the mean, the standard deviation, the median, and the interquartile range will be calculated. By allowing the comparison between the statistics of the entire group of experts and the statistics of the individuals' responses to take place, the opportunity to reconsider one's own opinions will be given. In addition, in order to determine the validity of each component, the content validity ratio, as well as the degree of consensus and convergence will be calculated. The CVR was calculated using the calculation formula made by Lawshe [41], Park Seon Yeong [42]. 25% and 75%. The following are the formulas to calculate the degree of consensus and convergence [43].

The statistical analyses of each stage will utilize the open-ended question survey and the papers of evaluation that used
Likert's five point scale. The second survey was a survey using Likert's five point scale, based on the organized results from the first survey; the degree of consensus regarding questions for each category was presented using the second evaluation paper. The third survey will evaluate the degree of consensus for the questions of each category questions which will be made by utilizing the same methods as that of the second survey. The answers collected at each stage were be checked for any omissions, and were be entered into the computer one by one in the form of data which can be analyzed; then the frequencies program of SPSS (ver.23.0) was used to calculate the frequency distribution, and the average difference between the results, as well as their Ⅹ², were verified. The level of significance was set to p<.05.

Results
A survey regarding the development of the cranial traction therapy program was conducted. The validity and the verification for the study's homogeneity (credibility), which were the points of evaluation for this study according to the survey results, were then analyzed through survey questions, which consisted of the three open-ended ones regarding the duration application time, application frequency, and application intensity, along with the close-ended ones which were made up of the aforementioned 14 items. The results of the development of the cranial traction therapy program for the correction of facial asymmetry can be seen in Table 5. & Table 6 and suitable questions. Also, as can be seen in Table 5, Table6, the results regarding the degree of importance for each of the points of evaluation made by the groups of experts in both the second and third stage of the cranial traction therapy program were verified using content validity ratio (CVR 77). The ratio for the 13 points of evaluation was within the range of 0.40∼1.00, so the Delphi program for the cranial traction therapy verified that the content was valid. As shown at Table 7, the adopted results for questions that did not show adequate levels of significance (p<.05) by the verification of the homogeneity (credibility) are as follows.

Discussion
As the suture lines of the cranial are small amounts of connective tissue interposed in between the bones, thereby connecting them, each parts of the cranial can be divided into their individual parts [44]. Through this division, this study established and categorized each items of cranial traction therapy as can be seen in Table 3.
The treatment program of this study ultimately follows that in the book Cranial Osteopathy (Principles and Practice)by Torsten Liem [45], in that it performs traction at the parts that the book deemed as effective for correction therapy. These The results of the precedent studies regarding items #1-14 are as follows. The validity and the credibility of the development of this program was verified by an expert, and it was ascertained that all the items were effective in bringing about facial symmetry and are useful items to be applied in an alternative therapy. Also, the treatment points were chosen, as can be seen in Table 2, according to the stimulation methods for traction therapy. Item #1 was the coronal suture part; item #8 the squamous suture part; #9 the lambdoid suture part; #6 the sagittal suture part, at which three points were treated; items #2, #3, #4, #5, #7, #10, #11, #12, and #13 were the sphenofrontal suture, the sphenoparietal suture, the occipitomastoid suture, and the sphenosquamous suture parts, and for those items one point was treated respectively.
In regards to the points of evaluation for stages 1, 2, and 3 of this cranial traction therapy program, in which its validity and homogeneity (credibility) were verified, #4 was deleted out of the 14 items after it did not meet the criteria of evaluation, and thus 13 items were evaluated. The figures representing the consensus regarding the development of this program can be seen in Table 3.
The categorization of each item in this study can be found in some manual treatment therapies of skin care that use similar methods as this one. However, there has never been an authorized care program that involves cranial traction therapy that is based on scientific analyses and data, as well as one that involves the correction of facial asymmetry through the former. The program will be used in the dental and medical world, as well as in some skin care academies and associations, to theorize the correction of facial asymmetry. It has validity and credibility as a program that can correct facial asymmetry by stimulating the suture parts of the cranial through traction therapy, and through its commercialization, it will contribute to the correction and prevention of facial deformities.
This study shows that it is possible to change the shape of the face by applying pressure to the cranial before getting correction for facial asymmetry. In cases where facial asymmetry has occurred due to one's environment after birth, it shows that if plagiocephaly (of the cranial's soft tissues) is treated by applying pressure to parts of the cranial, it is possible to prevent facial deformity or asymmetry that would have ensued otherwise, allowing one to retain a harmonious face shape.

Conclusions
The purpose of this study was to develop a cranial traction therapy program that will correct facial asymmetry. In order to do this, it utilized the cranial traction therapy that was suggested by a group of experts; and by testing its validity and credibility, a cranial traction therapy program that could be used to correct facial asymmetry was developed. The purpose Preprints (www.preprints.org) | NOT PEER-REVIEWED | Posted: 27 October 2020 doi:10.20944/preprints202010.0537.v1 of this study and alternative measures were provided as the study's baseline data. The program will have utility for improving facial asymmetry, and can be used as a supplementary therapy or a special care therapy to help achieve balance.
Author Funding: This research received no external funding.